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

Inclusion criteria

• Aged 18 to 85 years, gender not restricted;
• Rutherford grade 2 to 5
• 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)
• At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
• The guidewire can successfully pass through the target lesion site within the vascular lumen;
• Agree to participate in this clinical study and voluntarily sign the informed consent form.

Exclusion criteria

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