Clinical Research Directory

Inclusion Criteria: * Subject age 18-85yrs. * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form. * Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing. * Rutherford category 2-5. * Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment). * Patent inflow artery with stenosis \<30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis). * A guidewire has successfully traversed the target treatment segment. Exclusion Criteria: * Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia. * Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis. * Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention. * Subject has an uncontrolled thrombophilia or hypercoagulable state. * Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year. * Subject has contraindications or intolerance to antiplatelet/anticoagulant medications, such as aspirin, clopidogrel, or heparin. * Subject is pregnant or breastfeeding. * Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke. * Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.