Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System

Inclusion Criteria:

1. Age of subject is greater than or equal to 18.
2. Rutherford Grade 2~5;
3. The resting ABI of target limb ≤0.90, or ≤0.75 after exercise;
4. Agree to participate in this study and sign informed consent;
5. Estimated life expectancy >1 year.
6. According to the diagnosis of medical institutions or participating researchers,peripheral arterial tubuloplasty (including peripheral seismic catheterization systemor peripheral vascular balloon dilatation catheter for lumen preparation, andsubsequent drug-coated balloon therapy or stent implantation; Angiographic InclusionCriteria
7. Target lesion that is located in a native, de novo superficial femoral artery (SFA) orpopliteal artery (popliteal artery extends to and ends proximal to the ostium of theanterior tibial artery).
8. The target vessel has not received any prior surgical intervention (within 3 months),including endovascular therapy and open surgery, and the stenosis rate ≥ 50% orocclusive lesions were assessed preoperatively;
9. The target vessels were 2-7.5 mm in diameter and had at least one normal subgenicularoutflow artery (stenosis rate ≤50%).
10. If the stenosis rate of the target lesion is 50-99% and the lesion length is less thanor equal to 260mm, the target lesion may be continuous or intermittent, or both. Ifthe target lesions were chronic occlusive lesions, the length of occlusive lesions was ≤100mm, and the total length of lesions was ≤260mm;
11. The calcification degree is at least moderate, which is defined as the presence ofcalcification signs in the vessels of the target lesions under CTA or fluoroscopy, andthe calcification conditions are 1) located on both sides of the target lesions, 2) ifthe length of the target lesions is less than 50mm, the length of the calcificationlesions is at least 20mm; If the target lesion length ≥50mm and < 100mm, thecalcification lesion length should be at least 50% of the target lesion. If the targetlesion length is ≥100mm, the calcification lesion length should be greater than 50mm.
12. If there are signs of acute or chronic thrombus in the target blood vessels, the aboveconditions are met after routine clinical treatment. Note: Patients with inflow tract and outflow tract that are qualified for inclusion in thisstudy after routine clinical treatment can be included. cc

Exclusion Criteria:

1. The Rutherford rating is 0, 1 and 6;
2. Severe infection of target limb requiring antibiotics or planned amputation above theankle;
3. Previous intra-arterial therapy or open surgery had been performed on the target limb (within 1 month);
4. Coagulation abnormalities are known to exist;
5. Coagulation abnormalities are known to exist;
6. A history of stroke or myocardial infarction within 60 days;
7. Subjects who have participated in clinical trials of other medical devices or drugsduring the same period;
8. Women who are pregnant or breastfeeding;
9. Other conditions that the investigator considers inappropriate for clinical trialparticipation; Angiographic Exclusion criteria
10. in-stent restenosis
11. A highly tortuous artery;
12. The inflow vessels upstream of the target lesion area have other obvious vascularlesions that have not been successfully treated (stenosis rate > 50%);
13. There is an aneurysm in the target vessel.