Peripheral Arterial Disease
Conditions
Interventions
Treatment group:Peripheral seismic catheterization system (IVL) + drug-coated balloon (DCB) and/or stent
Control group:PTA + DRUG-coated balloon (DCB) and/or stent
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age of the subject is greater than or equal to 18; 2. Rutherford Grade 2~5; 3. The resting ABI of target limb 1 year; 6. According to the diagnosis of medical institutions or participating researchers, peripheral arterial tubuloplasty (including peripheral seismic catheterization system or peripheral vascular balloon dilatation catheter for lumen preparation, and subsequent drug-coated balloon therapy or stent implantation; 7. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior 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% or occlusive lesions were assessed preoperatively; 9. The target vessels were 2-7.5 mm in diameter and had at least one normal subgenicular outflow artery (stenosis rate =50mm and =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 above conditions are met after routine clinical treatment. Note: Patients with inflow tract and outflow tract that are qualified for inclusion in this study after routine clinical treatment can be included.
Exclusion criteria
Exclusion criteria: 1. Severe infection of target limb requiring antibiotics or planned amputation above the ankle; 2. Previous intra-arterial therapy or open surgery had been performed on the target limb (within 1 month); 3. Coagulation abnormalities are known to exist; 4. Coagulation abnormalities are known to exist; 5. A history of stroke or myocardial infarction within 60 days; 6. Subjects who have participated in clinical trials of other medical devices or drugs during the same period; 7. Women who are pregnant or breastfeeding; 8. Other conditions that the investigator considers inappropriate for clinical trial participation; 9. In-stent restenosis; 10. A highly tortuous artery; 11. The inflow vessels upstream of the target lesion area have other obvious vascular lesions that have not been successfully treated (stenosis rate > 50%); 12. There is an aneurysm in the target vessel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical Success Rate, TSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesion;New-onset Major Adverse Events (MAEs);Clinical Success ABI;Clinical Success Rutherford Category;Performance of Device;Intraoperative complication;Device defect (for test group only); | — |
Countries
China
Contacts
Public ContactXinwu Lu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed