This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months.
Aged 18 to 80 years, regardless of gender.
Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5.
Subject (or legal guardian, if applicable) is willing and able to provide consent before to the performance of any study-specific tests or procedures, has signed the consent form and agrees to attend all required follow-up visits.
Degree of stenosis ≥70% by visual angiographic assessment.
Pregnant or breastfeeding women, or women/men planning to conceive.
Subjects who have had or are planned for major amputation (at or above the ankle level).
Subjects known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, contrast agents, etc.
Subjects with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.