During the operation, quantitative angiography was performed before, during, after and during follow-up of balloon placement. The images and vascular dimensions of the balloon expansion catheter were recorded and saved. The results showed that the mean value of the maximum stenosis percentage at 28 days follow-up was 5.80%5.80 \% . The DSA angiography results showed that the overlap length of the balloon overlap test segment was greater than 10 mm, and the blood vessels showed slight stenosis during follow-up, which may be caused by endothelial hyperplasia and lumen occupancy. Table 23-Table 24 shows the general overview of QVA analysis of the experimental animal blood vessels. DSA images of one animal each from the immediate post-operative group and the 28D group were selected and shown in Figure 4-Figure 5. For details of the vascular dimensions of each animal before and after balloon dilation and during follow-up, please refer to Appendix 5, and DSA images to Appendix 6.
## Table 25 QVA Analysis Results at the Immediate Time Point
Figure 4 shows the DSA image of the subject P02644 at the moment. Figure 4-a is the angiography image before the test balloon is placed in the left superficial femoral artery; Figure 4-b is the angiography image when the test balloon expands the left superficial femoral artery at the distal end of the vessel; Figure 4-c is the angiography image when the test balloon expands the left superficial femoral artery at the proximal end of the vessel, showing that the vascular condition is normal after the balloon is placed; Figure 4-d is the angiography image of the left superficial femoral artery after balloon expansion, showing that the vascular condition is normal. Figure 4-e is the angiography image before the test balloon is placed in the right superficial femoral artery; Figure 4-f is the angiography image when the test balloon expands the right superficial femoral artery at the distal end of the vessel; Figure 4-g is the angiography image when the test balloon expands the right superficial femoral artery at the proximal end of the vessel; Figure 4-h is the angiography image of the right superficial femoral artery after balloon expansion, showing that the vascular condition is normal. Figure 4-i is the angiography image before the damaged balloon is placed in the left deep femoral artery, and Figure 4-j is the angiography image after the damaged balloon is placed in the left deep femoral artery; Figure 4-k is the angiography image before the damaged balloon is placed in the right deep femoral artery, and Figure 4-l is the angiography image after the damaged balloon is placed in the right deep femoral artery.
Figure 5 is a DSA image of animal number P02642 at 28 days. Figure 5-a is a pre-test angiographic image of the test product balloon inserted into the left femoral superficial artery; Figure 5-b is an angiographic image of the test product balloon expanding the left femoral superficial artery distally; Figure 5-c is an angiographic image of the test product balloon expanding the left femoral superficial artery proximally, showing that the balloon is placed in the vessel after expansion.
Status normal; Figure 5-d is the angiographic image of the left superficial femoral artery after balloon dilation, showing normal blood vessel status; Figure 5-e is the angiographic image of the test balloon placed in the left superficial femoral artery at 28 days follow-up; Figure 5-f is the angiographic image before the test balloon is placed in the right superficial femoral artery; Figure 5-g is the angiographic image of the test balloon in the distal right superficial femoral artery when it is being dilated; Figure 5-h is the angiographic image of the test balloon in the right superficial femoral artery when it is being occluded for dilation; Figure 5-i is the angiographic image of the right superficial femoral artery after balloon dilation, showing normal blood vessel status. Figure 5-j is the angiographic image of the right superficial femoral artery at 28 days follow-up after balloon dilation, showing normal blood vessel status. Figure 5-k is the angiographic image of the left profunda femoral artery before the placement of the damaged balloon, Figure 5-I is the angiographic image of the left profunda femoral artery after the placement of the damaged balloon; Figure 5-m is the angiographic image of the left profunda femoral artery at 28 days follow-up after the placement of the damaged balloon; Figure 5-n is the angiographic image of the right profunda femoral artery before the placement of the damaged balloon, Figure 5-o is the angiographic image of the right profunda femoral artery after the placement of the damaged balloon; Figure 5-p is the angiographic image of the right profunda femoral artery at 28 days follow-up after the placement of the damaged balloon.
18.9 Gross anatomical examination
This study involved 5 animals in the experiment. The animals were euthanized after the follow-up point of the experiment, and a gross autopsy was performed. The results showed that no abnormalities were observed during the gross autopsy of the animals, and no abnormalities were observed with the naked eye on the blood vessels, distal muscles (gastrocnemius, semitendinosus, semimembranosus), and major organs (heart, liver, spleen, lungs, kidneys) of the test site. The results showed that the peripheral arterial shock wave lithotripsy system used in the peripheral blood vessels of the experimental animals did not have adverse effects on the local blood vessels of the experimental animals, nor did it have adverse effects on the distal muscles and major organs of the experimental animals.
Animals numbered P02641 that were selected for the 28d time point were dissected, and the results are shown below. The macroscopic dissection images of each animal are shown in Attachment 7.
Figure 6-c Right femoral artery (in vivo) Figure 6-d Right femoral superficial artery (ex vivo)
Figure 6-e Left hemidiaphragmatic muscle Figure 6-f semimembranosus muscle on the right, right semimembranosus muscle
Figure 6-g Left semitendinosus muscle Figure 6-h right semitendinosus muscle
