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.
(1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (3) 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.
Vessel diameter ≥4.0 mm and ≤6.5 mm.
Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
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
Peripheral Drug-eluting Stent System
DeviceDrug-eluting stents (DES) are increasingly used in the treatment of PAD. These stentsare coated with antiproliferative drugs designed to provide mechanical support within the artery while releasing the drug gradually to reduce the risk of restenosis. Commonly used drugs include paclitaxel, sirolimus, and everolimus, which inhibit vascular smooth muscle cell proliferation, thereby reducing the likelihood of re-occlusion.
Primary patency at 12 months post-procedure
Primary vessel 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.
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MDCECRO LLC
Lead sponsor
Zylox-Tonbridge Medical Technology Co., Ltd.
Collaborator
