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.
Single group
ZENFLEX Pro™ Peripheral Drug-eluting Stent System
DeviceThe ZENFLEX Pro™ Peripheral Drug-eluting Stent System will be implanted in patients with femoropopliteal artery lesions to evaluate safety and efficacy outcomes. The device is designed to provide mechanical support and deliver antiproliferative drug locally to reduce restenosis. The procedure will be performed via standard endovascular techniques.
Number of Participants Reaching Primary Patency
Primary patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.
Number of participants with successful stent delivery and deployment resulting in ≤30% residual stenosis
Technical success is defined as the delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually.
Number of participants with procedural success (technical success and no MAEs within 24 hours)
Procedural success is defined as technical success with no major adverse events (MAEs) noted within 24 hours of the index procedure.
Number of participants with primary patency
Primary patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.
Number of participants with secondary patency
Secondary patency at 6 months and 12 months. Secondary patency is defined as the absence of restenosis in the target lesion on DUS follow-up, with a diameter stenosis of ≤50% (PSVR ≤2.4), regardless of whether the target lesion has undergone reintervention.
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