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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
Last Update Posted 2024-03-15
上次更新发布时间:2024-03-15

Study Overview 研究概述

Brief Summary 小结
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。
Show less  显示简要信息
Detailed Description 详细说明

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。

Show less  显示简要信息
Official Title 官方职称
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

Contacts and Locations 联系人和位置

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。

United States 美国
California Locations 加州地点
Los Angeles, California, United States, 90027
洛杉矶、加利福尼亚州、美国、90027

Kaiser Permanente
Florida Locations 佛罗里达地点
Jacksonville, Florida, United States, 32207
Jacksonville、Florida、美国、32207

Baptist Health 浸信会健康
Illinois Locations 伊利诺伊州地点
Chicago, Illinois, United States, 60612
Chicago、Illinois、美国、60612

Rush University Medical Center
拉什大学医学中心

Indiana Locations 印第安纳州地点
Indianapolis, Indiana, United States, 46260
印第安纳波利斯、印第安纳州、美国、46260

Ascension St. Vincent Hospital
阿森松圣文森特医院

Iowa Locations 爱荷华州地点
Iowa City, Iowa, United States, 52242
爱荷华市, 艾奥瓦州, 美国, 52242

University of Iowa Hospitals and Clinics
爱荷华大学医院和诊所

Kansas Locations 堪萨斯州地点
Kansas City, Kansas, United States, 66160
堪萨斯城, 堪萨斯, 美国, 66160

University of Kansas Medical Center
堪萨斯大学医学中心

Michigan Locations 密歇根州地点
Grand Rapids, Michigan, United States, 49503
Grand Rapids、Michigan、美国、49503

Spectrum Health Hospital 光谱健康医院
New York Locations 纽约地点
Valhalla, New York, United States, 10595
Valhalla、New York、美国、10595

Westchester Medical Center
威彻斯特医疗中心

Ohio Locations 俄亥俄州地点
Cleveland, Ohio, United States, 44106
Cleveland、Ohio、美国、44106

University Hospitals Cleveland Medical Center
克利夫兰大学医院医学中心

Cleveland, Ohio, United States, 44195
Cleveland、Ohio、美国、44195

Cleveland Clinic Foundation
克利夫兰诊所基金会

Columbus, Ohio, United States, 43214
Columbus、Ohio、美国、43214

Riverside Methodist Hospital - OhioHealth
河滨卫理公会医院 - 俄亥俄州健康

Pennsylvania Locations 宾夕法尼亚州地点
Abington, Pennsylvania, United States, 19001
Abington、Pennsylvania、美国、19001

Abington Jefferson Health
阿宾顿杰斐逊健康

Philadelphia, Pennsylvania, United States, 19104
Philadelphia、Pennsylvania、美国、19104

The Hospital of the University of Pennsylvania
宾夕法尼亚大学医院

Philadelphia, Pennsylvania, United States, 19107
Philadelphia、Pennsylvania、美国、19107

Thomas Jefferson University Hospital
托马斯杰斐逊大学医院

Tennessee Locations 田纳西州地点
Memphis, Tennessee, United States, 38163
Memphis、Tennessee、美国、38163

Semmes Murphey Clinic - University of Tennessee Health Science Center
Semmes Murphey 诊所 - 田纳西大学健康科学中心

Texas Locations 德克萨斯州地点
Austin, Texas, United States, 78712
Austin、Texas、美国、78712

Dell Seton Medical Center at the University of Texas at Austin
德克萨斯大学奥斯汀分校戴尔西顿医疗中心

Harlingen, Texas, United States, 78550
Harlingen、Texas、美国、78550

Valley Baptist Medical Center
山谷浸信会医疗中心

Houston, Texas, United States, 77030
Houston、Texas、美国、77030

The University of Texas Health Science Center at Houston
德克萨斯大学休斯顿健康科学中心

Wisconsin Locations
Milwaukee, Wisconsin, United States, 53215

Ascension Wisconsin
Australia
New South Wales Locations
Liverpool, New South Wales, Australia

Liverpool Hospital - South Western Sydney Clinical School
South Australia Locations
Adelaide, South Australia, Australia

The Royal Adelaide Hospital (RAH)
Victoria Locations
Melbourne, Victoria, Australia

Royal Melbourne Hospital
Canada
Alberta Locations
Edmonton, Alberta, Canada, T6G 2B7

University of Alberta
Ontario Locations
Toronto, Ontario, Canada

University Health Network - Toronto Western Hospital
New Zealand
Canterbury Locations
Christchurch, Canterbury, New Zealand

Christchurch Hospital
Spain
Badalona, Spain

Hospital Universitario Germans Trias i Pujol
Barcelona, Spain

Hospital Clínic i Provincial de Barcelona
Barcelona, Spain

Hospital Universitari de Bellvitge
Barcelona, Spain

Hospital Universitari Vall d'Hebron
Valladolid, Spain

Hospital Clínico Universitario de Valladolid
Switzerland
Basel, Switzerland

Universität Basel
Click to view interactive map 点击查看互动地图

Participation Criteria 参与标准

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。


For general information about clinical research, read
有关临床研究的一般信息,请阅读
Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies). 了解学习。
Eligibility Criteria 资格
Description 描述

Inclusion Criteria: 纳入标准:

  1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
    最终诊断为急性缺血性中风的成人(18-85 岁)
  2. NIH Stroke Scale Score (NIHSS) ≥ 6
    美国国立卫生研究院卒中量表评分 (NIHSS) ≥ 6
  3. Last known well to groin puncture or medical management between 0 to 24 hours
    腹股沟穿刺或医疗管理的最后已知时间在 0 至 24 小时之间
  4. Pre-stroke modified Rankin Scale score (mRS) of 0-1
    卒中前改良 Rankin 量表评分 (mRS) 为 0-1
  5. Eligible for thrombectomy or medical management
    符合血栓切除术或医疗管理条件
  6. Signed Informed Consent obtained
    获得签署的知情同意书
  7. Subject willing to comply with the protocol follow-up requirements
    受试者愿意遵守协议后续要求
  8. 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:

  1. 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
  2. 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),
    • 2.2. CT perfusion (rCBF<30% ≥50cc),
      2.2. CT灌注(rCBF<30%≥50cc),
    • 2.3. MRI-DWI (ADC<620 ≥50cc)
      2.3. 磁共振成像(MRI-DWI)(ADC<620≥50cc)

Exclusion Criteria: 排除标准:

  1. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
    无法接受 CT 血管造影和/或 CT 灌注成像(例如,肾功能不全、碘/造影剂过敏)
  2. Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
    会混淆神经系统评估的共病精神或医学疾病
  3. Treatment with thrombolytic agent beyond 4.5 hours from last known well
    使用溶栓剂治疗超过上次已知孔 4.5 小时
  4. Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:
    在最后一次已知良好后 3-4.5 小时用溶栓剂治疗,并且有以下任何一种情况:

    • 1) age >80, 1) 年龄>80岁,
    • 2) current anticoagulant use,
      2)目前使用抗凝剂,
    • 3) history of diabetes AND prior stroke,
      3)糖尿病史和既往中风史,
    • 4) NIHSS >25, 4) 美国国立卫生研究院 >25,
    • 5) ischemic involvement of > 1/3 MCA territory
      5) > 1/3 MCA 区域缺血受累
  5. 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

  1. 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
  2. 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
  3. 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
  4. A significant mass effect with midline shift
    伴有中线偏移的显著质量效应
  5. 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
  6. 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
  7. 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)。
  8. 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
Show less  显示简要信息
Ages Eligible for Study
符合学习条件的年龄
18 Years to 85 Years (AdultOlder 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 
Accepts Healthy Volunteers
接受健康志愿者
No 

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。

/
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。

Study Record Dates 学习记录日期

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
2024-02-15
Last Update Posted  最后更新发布
2024-03-15
Last Verified  上次验证
2024-02

More Information 更多信息

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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