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.
Aged 18 to 85 years, gender not restricted;
Rutherford grade 2 to 5
Diameter stenosis ≥70% by visual estimation or
Chronic total occlusion (CTO)
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.;
Single group
drug coating balloon angioplasty
DeviceThe subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions
Primary Patency Rate at 12 months post-procedure
12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis). Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis. Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.
Device Success Rate
Primary Patency Rate at 24 months post-procedure
Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure
Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively
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