Study record managers: refer to the Data Element Definitions if submitting registration or results information.
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:
The age groups are:
Child (birth-17)
Adult (18-64)
Older Adult (65+)
A measure of all deaths, due to any cause, that occur during a clinical study.
A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized.
A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm.
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled.
Information required by the Food and Drug Administration Amendments Act of 2007. In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed.
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification.
The date on which information about a certification to delay submission of results or an extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the first posted date.
The date on which the study sponsor or investigator first submitted a certification or an extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov (certification/extension first posted).
The date on which the study sponsor or investigator first submitted a certification or an extension request that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed.
In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the state, identifying "Chicago" as the city and "100 miles" as the distance will find all studies listing a location within 100 miles of Chicago.
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies.
Another name for an interventional study.
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a state and identifying a city and distance.
A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available:Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
No longer available:Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
Temporarily not available:Expanded access is not currently available for this intervention but is expected to be available in the future.
Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.
A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.
A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801).
The National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. This information is provided by the FDA. There are three categories of information that may be included:
Violation: Shown when the FDA issues a Notice of Noncompliance and posts the Notice of Noncompliance on its designated webpage. There are three types of violations:
Failure to submit required clinical trial information
Submission of false or misleading clinical trial information
Failure to submit primary and secondary outcomes
Correction: Shown when the FDA confirms that the responsible party has updated the study record to correct the violation and posts the correction notice on its designated webpage. Because of the time for FDA review and processing, there may be a delay between the date when the study record was updated and the addition of correction information to the FDAAA 801 Violation information.
Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on its designated webpage.
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study results database. For more information on FDAAA 801, see the Clinical Trial Reporting Requirements page on this site.
Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as sponsors and collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders:
U.S. National Institutes of Health
Other U.S. Federal agencies (for example, Food and Drug Administration, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs)
Industry (for example: pharmaceutical and device companies)
All others (including individuals, universities, and community-based organizations)
A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based on a person's self-representation of gender identity. Gender identity refers to a person's own sense of gender, which may or may not be the same as their biological sex.
A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
A group of people who review, approve, and monitor the clinical study's protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.
A process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.
The document used in the informed consent or process.
The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment, parallel assignment, cross-over assignment, and factorial assignment.
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date).
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the last update submitted date; any country for which all facilities were removed from the study record are listed under removed location countries.
In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations.
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.
A patient registry is a type of observational study.
The general design of the strategy for identifying and following up with participants during an observational study. Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.
An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above.
Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to study records that contain these words.
For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort. This includes the number of participants who started, completed, and dropped out of the study.
A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Describes trials without FDA-defined phases, including trials of devices or behavioral interventions.
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
An arm type in which a group of participants receives a placebo during a clinical trial.
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
The person who is responsible for the scientific and technical direction of the entire clinical study.
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov.
Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator.
A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group.
The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator.
A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results "posted."
Note: The ClinicalTrials.gov results database became available in September 2008. Older studies are unlikely to have results available in the database.
Indicates that the sponsor or investigator submitted a certification or extension request.
The date on which summary results information was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay between the date the study sponsor or investigator first submits summary results information (the results first submitted date) and the results first posted date. Some results information may be available at an earlier date if Results First Posted with QC Comments.
The date on which summary results information was first available on ClinicalTrials.gov with quality control review comments from the National Library of Medicine (NLM) identifying major issues that must be addressed by the sponsor or investigator. As of January 1, 2020, initial results submissions for applicable clinical trials (ACTs) that do not meet quality control review criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Accordingly, the Results First Posted with QC Comments date may be earlier than the Results First Posted date for an ACT with summary results information that is not consistent with NLM quality control review criteria.
The date on which the study sponsor or investigator first submits a study record with summary results information. There is typically a delay between the results first submitted date and when summary results information becomes available on ClinicalTrials.gov (the results first posted date).
The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit results information one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator.
Indicates that the study sponsor or investigator has submitted summary results information for a clinical study to ClinicalTrials.gov but the quality control (QC) review process has not concluded.
The results submitted date indicates when the study sponsor or investigator first submitted summary results information or submitted changes to summary results information. Submissions with changes are typically in response to QC review comments from the National Library of Medicine (NLM). If there is a date listed for results submitted to ClinicalTrials.gov, but there is not a subsequent date listed for results returned after quality control review, this means that the submission is pending review by NLM.
In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.
A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
In Advanced Search, the Sort studies by option is used to change the order of studies listed on the Search Results page. You can sort by Relevance or Newest First:
Relevance: Studies that best match your search terms appear higher in the search results list. This is the default display for all searches.
Newest First: Studies with the most recent First posted dates appear higher in the search results list.
The organization or person who initiates the study and who has authority and control over the study.
In the search feature, the State field is used to find clinical studies with locations in a specific state within the United States. If you choose United States in the Country field, you can search for studies with locations in a specific state.
The written description of the statistical considerations and methods for analyzing the data collected in the clinical study.
Indicates the current recruitment status or the expanded access status.
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
The investigative methods and strategies used in the clinical study.
Refers to the type of documents that the study sponsor or principal investigator may add to their study record. These include a study protocol, statistical analysis plan, and informed consent form.
Identifiers that are assigned to a clinical study by the study's sponsor, funders, or others. They include unique identifiers from other trial study registries and National Institutes of Health grant numbers. Note: ClinicalTrials.gov assigns a unique identification code to each clinical study registered on ClinicalTrials.gov. Also called the NCT number, the format is "NCT" followed by an 8-digit number (for example, NCT00000419).
An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; contact information; and, in some cases, summary results. Each study record is assigned a ClinicalTrials.gov identifier, or NCT number.
A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies.
A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events).
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
The date on which the study sponsor or investigator submitted a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria.
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.
The acronym or initials used to identify a clinical study (not all studies have one). For example, the title acronym for the Women's Health Initiative is "WHI."
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
An agency within the U.S. Department of Health and Human Services. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.
An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.
A type of recruitment status. It identifies a study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been verified within the past 2 years. Studies with an unknown status are considered closed studies.
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ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The National Library of Medicine (NLM) maintains the website. The study sponsor or investigator submits information about their study to ClinicalTrials.gov and is responsible for the safety, science, and accuracy of any study they list.
Before joining a study, talk to your health care professional about possible risks and benefits. To learn more about taking part in studies, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Completed 完成
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT2) SELECT2：一项优化急性缺血性卒中患者血管内治疗选择的随机对照试验 （SELECT2）
ClinicalTrials.gov ID NCT03876457
Sponsor University Hospitals Cleveland Medical Center 赞助大学医院克利夫兰医学中心
Information provided by Amrou Sarraj, University Hospitals Cleveland Medical Center (Responsible Party) 信息由克利夫兰大学医院医学中心（责任方）的 Amrou Sarraj 提供
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well. SELECT 2 评估了血管内血栓切除术与单独药物治疗相比，在急性缺血性卒中患者中的疗效和安全性，这些患者是由于远端 ICA 和 MCA M1 中有大血管闭塞，这些患者在 CT 上（方面：3-5）或高级灌注成像（CTP 上的 [rCBF<30%] 或 MRI 上的 [ADC<620]：≥50cc） 或两者兼而有之，并在 0-24 小时内接受治疗。
SELECT 2 is a prospective, phase III randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either CT or advanced perfusion imaging treated within 0-24 hours from last known well. SELECT 2 是一项前瞻性、III 期、随机、国际、多中心、评估者盲法对照试验，旨在评估血栓切除术对 CT 或晚期灌注成像大核心患者的疗效和安全性，这些患者在距上次已知孔后 0-24 小时内接受治疗。
Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both within 0-24 hrs from last known well will be randomized in a 1:1 ratio into thrombectomy plus medical management vs medical management alone.
Patient outcomes will be measured at baseline, 24 hours post, discharge, 30 days and 90 days. 由于远端 ICA 和 MCA M1 大血管闭塞而最终诊断为急性缺血性卒中的患者，在 CT 上（方面：3-5）或高级灌注成像（CTP 上的 [rCBF<30%] 或 MRI 上的 [ADC<620]：≥50cc） 或两者兼而有之的患者将在 0-24 小时内以 1：1 的比例随机分配到血栓切除术加医疗管理与单独医疗管理。患者预后将在基线、出院后 24 小时、出院、30 天和 90 天时进行测量。
The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days.
The primary outcome is a shift on 90-day mRS.
Secondary outcomes are favorable clinical outcomes: mRS score of 0-2, safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization.
CT images will be read by iSchemaView automated ASPECTS as well as by a physician.
In cases where there is disagreement, the physician reading will override the automated software reading.
CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software.
All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston. 主要终点是 90 （+/- 15） 天时的改良 Rankin 量表 （mRS）。主要结果是 90 天 mRS 的转变。 次要结果是有利的临床结果：mRS 评分为 0-2，安全性结果，例如症状性颅内出血的发生率（根据 SITS-MOST）的发生率和成像终点，例如随机分组后 24 至 72 小时 MRI 弥散加权成像 （DWI） 序列（或 CT，如果 MRI 不可行，则为 CT）上的梗死体积。CT 图像将由 iSchemaView 自动 ASPECTS 和医生读取。如果存在分歧，医生读数将覆盖自动软件读数。具有错配测定的 CT/MR 灌注图像将由 iSchemaView 自动 RAPID 软件读取。所有图像将由德克萨斯大学休斯顿医学院的盲法核心实验室进行裁决。
A maximum of 560 patients will be randomized across the study sites.
Covariate adaptive randomization will be used to balance the distribution of important variables.
Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility. 最多 560 名患者将被随机分配到研究地点。协变量自适应随机化将用于平衡重要变量的分布。中期分析将在 200 名和 380 名患者中进行，届时研究可能会因有效或无效而停止。
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke SELECT2：一项优化急性缺血性卒中血管内治疗患者选择的随机对照试验
Conditions 条件
Acute Ischemic Stroke 急性缺血性脑卒中
Intervention / Treatment 干预/治疗
Device: Endovascular Thrombectomy 设备：血管内血栓切除术
Other: Medical Management 其他：医疗管理
Device: Endovascular Thrombectomy
Other: Medical Management
Other Study ID Numbers 其他研究 ID 号
G180275, Pro00056862 G180275，Pro00056862
Study Start (Actual) 学习开始（实际）
2019-10-11
Primary Completion (Actual) 小学完成时间（实际）
2022-11-20
Study Completion (Actual) 学习完成（实际）
2023-11-16
Enrollment (Actual) 注册（实际）
352
Study Type 研究类型
Interventional 介入
Phase 阶段
Not Applicable 不適用
MedlinePlus(https://medlineplus.gov/) related topics: Ischemic Stroke(https://medlineplus.gov/ischemicstroke.html) MedlinePlus 相关主题： 缺血性卒中
This section provides the contact details for those conducting the study, and information on where this study is being conducted. 本节提供进行研究的人员的联系方式，以及有关该研究进行地点的信息。
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. 研究人员寻找符合某种描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
Eligible for thrombectomy or medical management 符合血栓切除术或医疗管理条件
Signed Informed Consent obtained 获得签署的知情同意书
Subject willing to comply with the protocol follow-up requirements 受试者愿意遵守协议后续要求
Anticipated life expectancy of at least 3 months 预期寿命至少为 3 个月
Specific Neuroimaging Inclusion Criteria: 具体神经影像学纳入标准：
Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA 经证实的 ICA 或 MCA-M1 闭塞（颈动脉闭塞可以是颈部或颅内，伴或不伴串联 MCA 病变）中的大血管闭塞由 MRA 或 CTA 确定
Large infarct-core lesion on at least one of the following: 以下至少一项出现大梗死核心病变：
2.1.
Non-Contrast CT (ASPECTS of 3-5), 2.1. 非增强 CT（3-5 方面），
Current participation in another investigational drug or device study. 目前正在参与另一项研究药物或设备研究。
Neuroimaging Exclusion Criteria 神经影像学排除标准
Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on perfusion imaging 非增强 CT 上 6-10 个方面和灌注成像上核心体积 <50 cc 的患者
Patients with very large core on non-contrast CT i.e.
ASPECTS ≤ 2 非增强 CT 上核心非常大的患者，即 方面 ≤ 2
Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 颅内肿瘤（小脑膜瘤除外）、急性颅内出血、肿瘤或动静脉畸形的证据
A significant mass effect with midline shift 伴有中线偏移的显著质量效应
Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 颈内动脉夹层（血流受限或主动脉夹层）的证据
Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 颅内支架植入同一血管区域，妨碍了神经血栓切除术装置的安全部署/移除
Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion). CTA/MRA 确认的多个血管区域的急性症状性动脉闭塞（例如，双侧 MCA 闭塞，或 MCA 和基底动脉闭塞）。
Signs of established infarct and large area of cerebral edema on non-contrast CT 非增强 CT 显示已确诊梗死和大面积脑水肿的体征
18 Years to 85 Years (Adult, Older Adult )
18年 至 85年 （成人、年长者）
Sexes Eligible for Study 符合学习条件的性别
All 都
Accepts Healthy Volunteers 接受健康志愿者
No 不
Study Plan 学习计划
This section provides details of the study plan, including how the study is designed and what the study is measuring.
本节提供研究计划的详细信息，包括研究的设计方式和研究的测量内容。
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Design Details 设计细节
Primary Purpose : Treatment 主要目的 ： 治疗
Allocation : Randomized 分配 ： 随机分配
Interventional Model : Parallel Assignment 介入模式：并行分配
Masking : Single (Outcomes Assessor)
掩蔽：单一（结果评估员）
Arms and Interventions 武器和干预
Participant Group/Arm 参与者组/组
Intervention/Treatment 干预/治疗
Participant Group/Arm
Experimental: Endovascular Thrombectomy plus Medical Management 实验性的：血管内血栓切除术加医疗管理
Intervention/Treatment
Device: Endovascular Thrombectomy 设备：血管内血栓切除术
Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management.
They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset.
The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g.
MicroVention SOFIA Catheter, and the Penumbra thrombectomy system).
The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them. 随机分配到血管内血栓切除术组的患者将接受血栓切除术和药物治疗。他们将接受血栓切除术装置（支架取回器或抽吸装置）治疗，这些装置目前已被 FDA 批准用于在症状出现后 24 小时内经历急性中风的患者清除血栓。将使用的设备是 FDA 批准的支架取回器：Trevo Retriever、Solitaire 血运重建装置、EmboTrap 血运重建装置和 Tigertriever 血运重建装置;和/或 FDA 批准的抽吸装置（例如 MicroVention、SOFIA 导管和半影血栓切除术系统）。血栓切除术方法、主要方法/技术的选择，无论是原发性抽吸还是有或不有抽吸的初级支架取回器，都将由干预医生决定，研究方案中批准的任何 FDA 批准的设备或它们的组合。
Other: Medical Management 其他：医疗管理
Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines.
For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy.
Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning.
Post-thrombolysis patients will be treated based on standard study site protocols for these patients. 患者将接受标准的 AHA 指南指导的药物治疗，其中包括根据实践指南可根据实践指南使用的静脉溶栓治疗，用于在最后一次就诊后 3 小时内就诊并符合其他 FDA 标签标准的患者，或从最后一次就诊后最多 4.5 小时正常并符合其他 AHA 指南。对于非溶栓治疗的患者，这将包括第 1 天服用阿司匹林 325 毫克，之后服用阿司匹林 81 毫克或 325 毫克，这将由治疗医生和标准深静脉血栓形成预防治疗确定。如果没有明确的书面理由，将不鼓励静脉抗凝和双重抗血小板治疗。溶栓后患者将根据这些患者的标准研究现场方案进行治疗。
Participant Group/Arm
Active Comparator: Medical Management 有源比较器：医疗管理
Intervention/Treatment
Other: Medical Management 其他：医疗管理
Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines.
For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy.
Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning.
Post-thrombolysis patients will be treated based on standard study site protocols for these patients. 患者将接受标准的 AHA 指南指导的药物治疗，其中包括根据实践指南可根据实践指南使用的静脉溶栓治疗，用于在最后一次就诊后 3 小时内就诊并符合其他 FDA 标签标准的患者，或从最后一次就诊后最多 4.5 小时正常并符合其他 AHA 指南。对于非溶栓治疗的患者，这将包括第 1 天服用阿司匹林 325 毫克，之后服用阿司匹林 81 毫克或 325 毫克，这将由治疗医生和标准深静脉血栓形成预防治疗确定。如果没有明确的书面理由，将不鼓励静脉抗凝和双重抗血小板治疗。溶栓后患者将根据这些患者的标准研究现场方案进行治疗。
Primary Outcome Measures 主要结局指标
Outcome Measure 结果测量
Measure Description 措施说明
Time Frame 大体时间
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score 通过改良的 Rankin 量表 （mRS） 评分衡量的残疾/依赖程度
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 改良的 Rankin 量表 （mRS） 是一种常用的量表，用于衡量中风或其他神经残疾原因患者日常活动中的残疾或依赖程度。等级从 0-6 不等，“0”表示无症状的完美健康，“6”表示死亡。
Score 0: No symptoms Score 1: No significant disability.
Able to carry out all usual activities, despite some symptoms. 得分 0：无症状 得分 1：无严重残疾。尽管有一些症状，但能够进行所有日常活动。
Score 2: Slight disability.
Able to look after own affairs without assistance, but unable to carry out all previous activities. 得分 2：轻度残疾。能够在没有帮助的情况下处理自己的事务，但无法进行所有以前的活动。
Score 3: Moderate disability.
Requires some help, but able to walk unassisted.
Score 4: Moderately severe disability.
Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 得分 3：中度残疾。需要一些帮助，但可以独立行走。4分：中度残疾。在没有帮助的情况下无法满足自己的身体需求，也无法独立行走。
Score 5: Severe disability.
Requires constant nursing care and attention, bedridden, incontinent. 5分：严重残疾。需要持续的护理和照顾，卧床不起，大小便失禁。
Score 6: Dead 分数 6： Dead
90 days 90天
Secondary Outcome Measures 次要结局指标
Outcome Measure 结果测量
Measure Description 措施说明
Time Frame 大体时间
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up 在 90 天随访时以 mRS 评分为 0-2 衡量实现功能独立的参与者人数
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 改良的 Rankin 量表 （mRS） 是一种常用的量表，用于衡量中风或其他神经残疾原因患者日常活动中的残疾或依赖程度。等级从 0-6 不等，“0”表示无症状的完美健康，“6”表示死亡。
Score 0: No symptoms Score 1: No significant disability.
Able to carry out all usual activities, despite some symptoms. 得分 0：无症状 得分 1：无严重残疾。尽管有一些症状，但能够进行所有日常活动。
Score 2: Slight disability.
Able to look after own affairs without assistance, but unable to carry out all previous activities. 得分 2：轻度残疾。能够在没有帮助的情况下处理自己的事务，但无法进行所有以前的活动。
Score 3: Moderate disability.
Requires some help, but able to walk unassisted.
Score 4: Moderately severe disability.
Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 得分 3：中度残疾。需要一些帮助，但可以独立行走。4分：中度残疾。在没有帮助的情况下无法满足自己的身体需求，也无法独立行走。
Score 5: Severe disability.
Requires constant nursing care and attention, bedridden, incontinent. 5分：严重残疾。需要持续的护理和照顾，卧床不起，大小便失禁。
Score 6: Dead 分数 6： Dead
90 days 90天
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up 在 90 天随访时以 mRS 评分为 0-3 衡量实现独立行走的参与者人数
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 改良的 Rankin 量表 （mRS） 是一种常用的量表，用于衡量中风或其他神经残疾原因患者日常活动中的残疾或依赖程度。等级从 0-6 不等，“0”表示无症状的完美健康，“6”表示死亡。
Score 0: No symptoms Score 1: No significant disability.
Able to carry out all usual activities, despite some symptoms. 得分 0：无症状 得分 1：无严重残疾。尽管有一些症状，但能够进行所有日常活动。
Score 2: Slight disability.
Able to look after own affairs without assistance, but unable to carry out all previous activities. 得分 2：轻度残疾。能够在没有帮助的情况下处理自己的事务，但无法进行所有以前的活动。
Score 3: Moderate disability.
Requires some help, but able to walk unassisted.
Score 4: Moderately severe disability.
Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 得分 3：中度残疾。需要一些帮助，但可以独立行走。4分：中度残疾。在没有帮助的情况下无法满足自己的身体需求，也无法独立行走。
Score 5: Severe disability.
Requires constant nursing care and attention, bedridden, incontinent. 5分：严重残疾。需要持续的护理和照顾，卧床不起，大小便失禁。
Score 6: Dead 分数 6： Dead
90 days 90天
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria 根据 SITS-MOST 标准测量的患有症状性颅内出血 （sICH） 的患者人数
24 hours 24小时
Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself 神经系统恶化的参与者人数定义为由于中风本身导致 NIHSS 评分增加 ≥4 分
24 hours 24小时
Number of Mortalities Within 90-day Follow-up 90 天随访内的死亡人数
90 days 90天
Number of Procedural Complications 程序并发症的数量
The following were included in the complications counted: 以下并发症包括在计数中：
Surgical site hematoma 手术部位血肿
Surgical site infection 手术部位感染
Vascular injury (peripheral or intracranial dissection, perforation or others) caused by the endovascular procedure 血管内手术引起的血管损伤（外周或颅内夹层、穿孔或其他）
24 hours 24小时
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher EVT 组成功再灌注，定义为脑缺血改良溶栓 （mTICI） 等级为 2b 或更高
at the end of endovascular thrombectomy procedure 在血管内血栓切除术结束时
Discharge Location 出院地点
day 5-7 after randomization/at discharge (whichever is later) 随机分组后/出院时第 5-7 天（以较晚者为准）
Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of ≥8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1 显示早期神经系统改善的参与者人数，定义为在就诊 24 小时时 NIHSS 改善 ≥8 分或 NIHSS 为 0-1
24 hours 24小时
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up 生活质量评分，在 90 天随访时使用 NeuroQOL 测量
The Neurological Quality of Life score (NeuroQoL) is a patient-reported outcome measure that assesses the impact of neurological disorders on various aspects of a person's quality of life in neurological diseases and has measures developed across 17 different domains.
The trial measured NeuroQoL scores for Mobility, Depression, Social and Cognitive domains.
The scores provide a measure of an individual's quality of life in a given domain relative to a reference population, with a mean score of 50 and range of 0-100.
A t-score of 50 indicates average quality of life, while scores above 50 indicate better-than-average quality of life and scores below 50 indicate poorer-than-average quality of life, except for depression domain - where lower scores indicate better and higher scores indicate worse quality of life. 神经系统生活质量评分 （NeuroQoL） 是一种患者报告的结果测量方法，用于评估神经系统疾病对神经系统疾病患者生活质量各个方面的影响，并在 17 个不同领域开发了测量方法。该试验测量了移动性、抑郁、社交和认知领域的NeuroQoL评分。这些分数提供了相对于参考人群在给定领域中个人生活质量的衡量标准，平均得分为 50，范围为 0-100。t 分数为 50 表示平均生活质量，而高于 50 的分数表示生活质量优于平均水平，低于 50 的分数表示生活质量低于平均水平，但抑郁症领域除外——分数越低表示生活质量越好，分数越高表示生活质量越差。
90 days 90天
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score 1 年功能结果，通过改良的 Rankin 量表评分衡量
1 year 1年
Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up 功能独立性，定义为 1 年随访时 mRS 评分为 0-2
1 year 1年
Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up 独立行走，定义为 1 年随访时 mRS 评分为 0-3
1 year 1年
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up 生活质量评分，在 1 年随访时使用 NeuroQOL 测量
1 year 1年
Other Outcome Measures 其他结果指标
Outcome Measure 结果测量
Measure Description 措施说明
Time Frame 大体时间
Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) 24 Hours to 7 Days After Randomization 随机分组后 24 小时至 7 天 MRI DWI 序列上的梗死体积（如果 MRI 不可行，则为 CT）
24 hours to 7 days 24小时至7天
Lesion Growth Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume 基线影像学缺血核心与后续梗死体积之间的病变生长
24 hours to 7 days 24小时至7天
Number of Participants Who Suffered Parenchymal Hemorrhage Type 2 患有 2 型实质出血的参与者人数
24 hours 24小时
Number of Participants Who Suffered a Subarachnoid Hemorrhage 蛛网膜下腔出血的参与者人数
24 hours 24小时
Number of Participants Who Had a Hemicraniectomy During Index Hospitalization 在指数住院期间进行颅骨切除术的参与者人数
day 5-7 after randomization/at discharge (whichever is later) 随机分组后/出院时第 5-7 天（以较晚者为准）
Length of Hospital Stay 住院时间
Was assessed if the patient was discharged at every follow-up visit to determine the length of the stay if the patient was not discharged at the time of previous follow-up visit. 评估患者是否在每次随访时出院，以确定患者在上次随访时未出院的住院时间。
Up to 90-day follow up visit 长达 90 天的随访
Collaborators and Investigators 合作者和调查者
This is where you will find people and organizations involved with this study. 在这里，您可以找到参与这项研究的人员和组织。
Sponsor 发起人
University Hospitals Cleveland Medical Center 克利夫兰大学医院医学中心
Collaborators 合作
Stryker Neurovascular 史赛克神经血管
The University of Texas Health Science Center, Houston 德克萨斯大学休斯顿健康科学中心
Investigators 调查
Principal Investigator:Amrou Sarraj, MD,Case Western Reserve University - University Hospitals Cleveland Medical Center 首席研究员：Amrou Sarraj， MD、Case Western Reserve University - University Hospitals Cleveland Medical Center
Principal Investigator:(Australia and Oceania) Bruce CV Campbell, MBBS PhD,Melbourne Health 首席研究员：（澳大利亚和大洋洲） Bruce CV Campbell， MBBS PhD，Melbourne Health
Principal Investigator:(Europe) Marc Ribo, MD,Vall d'Hebron University Hospital, Barcelona 首席研究员：（Europe） Marc Ribo， MD、Vall d'Hebron University Hospital， Barcelona
Publications 出版物
From PubMed 来自 PubMed
These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study. 这些出版物来自PubMed，这是一个科学和医学文章的公共数据库。此列表由 ClinicalTrials.gov 标识符（NCT 编号）自动创建，这些文章可能与该研究有关，也可能与该研究无关。
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website. 这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由美国国家医学图书馆 （NLM） 审查，以确保它们符合特定的质量控制标准，然后再发布在公共网站上。
Study Registration Dates 学习注册日期
First Submitted 首次提交
2019-03-08
First Submitted that Met QC Criteria 首次提交符合QC标准
2019-03-12
First Posted 首次发布
2019-03-15
Results Reporting Dates 业绩报告日期
Results First Submitted 首次提交的结果
2023-11-20
Results First Posted with QC Comments 结果首次发布与QC评论
2023-12-13
Results First Submitted that Met QC Criteria 首次提交符合QC标准的结果
2024-02-15
Results First Posted 首次发布的结果
2024-03-15
Study Record Updates 研究记录更新
Last Update Submitted that met QC Criteria 上次更新 提交符合QC标准
Keywords Provided by Amrou Sarraj, University Hospitals Cleveland Medical Center 关键词 provided by Amrou Sarraj， University Hospitals Cleveland Medical Center
Additional Relevant MeSH Terms 其他相关 MeSH 术语
Plan to Share Individual Participant Data (IPD)? 计划共享个人参与者数据 （IPD）？
No 不
Studies a U.S. FDA-Regulated Drug Product 研究美国FDA监管的药品
No 不
Studies a U.S. FDA-Regulated Device Product 研究美国 FDA 监管的器械产品
Yes 是的
Study Documents Provided by Amrou Sarraj, University Hospitals Cleveland Medical Center 研究文件由克利夫兰大学医院医学中心的 Amrou Sarraj 提供
