Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions

This is a prospective, multi-center, single-arm, post-market registry study designed to ensure continued evaluation of real-world safety, performance and efficacy of the ZENFLEX Pro™ Peripheral Drug-eluting Stent System in the treatment of femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be enrolled in this study. Follow-up visits will be scheduled at 1-, 6-, and 12-months post-procedure. The primary endpoint is primary patency at 12 months. Secondary endpoints include technical success, procedural success, secondary patency rate, target lesion revascularization (TLR), clinically driven target lesion revascularization (CD-TLR), Rutherford classification, and ankle-brachial index (ABI). Safety endpoints include major adverse events, adverse events, all-cause mortality, major amputations, minor amputations, and stent fractures.

Inclusion criteria

• Clinical Inclusion Criteria:

• 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.
• Angiographic Inclusion Criteria:

• Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e., within the P1 segment):

• 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).
• Chronic total occlusion with a total lesion length of ≤120 mm.
• Patent popliteal and infrapopliteal arteries, with single-vessel runoff or better, defined as at least one of the three vessels remaining patent (i.e., <50% stenosis) down to the ankle or foot.

Exclusion criteria

• Clinical exclusion criteria:

• 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.
• Subjects with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≥2 times the upper limit of normal, or platelet count <80×10⁹/L).
• Previously stented target lesion/vessel.
• Target lesion/vessel previously treated with drug-coated balloon <12 months prior to enrollment.
• Subjects with a life expectancy of less than 1 year.
• Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
• Subjects diagnosed with major clinical diseases or unstable conditions within the past 3 months, such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack or stroke, severe neurological or psychiatric history, severe infections, gastrointestinal bleeding, or active disseminated intravascular coagulation.
• Subjects currently participating in another clinical trial involving drugs or medical devices.
• Subjects whom the investigator considers unsuitable for participation in the clinical trial.
• Angiographic exclusion criteria:

• Presence of aneurysm in the target vessel.
• Heavily calcified lesions (Peripheral Arterial Calcium Scoring System [PACSS] grades 3-4).
• The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.
• The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.
• Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment.