A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.

A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.

T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.

Inclusion Criteria:

1. Aged 18 to 85 years, gender not restricted;

2. Rutherford grade 2 to 5

3. Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:

   • Diameter stenosis ≥70% by visual estimation or
   • Chronic total occlusion (CTO)

4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;

5. The guidewire can successfully pass through the target lesion site within the vascular lumen;

6. Agree to participate in this clinical study and voluntarily sign the informed consent form.

Exclusion Criteria:

1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
2. Type D or higher dissection occurring after target lesion predilation;
3. Residual diameter stenosis >50% following target lesion predilation;
4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
5. Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;
7. Patients currently undergoing dialysis or immunosuppressive therapy;
8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;
9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;
10. Pregnancy or lactation women;
11. Currently participation in other drug/medical device clinical trials without completion;
12. Patients deemed by the investigator to be unsuitable for participation in this study.