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

Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions

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.

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:

  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.

• Angiographic Inclusion Criteria:

  1. 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):

     1. Degree of stenosis ≥70% by visual angiographic assessment.
     2. Vessel diameter ≥4.0 mm and ≤6.5 mm.
     3. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
     4. Chronic total occlusion with a total lesion length of ≤120 mm.

  2. 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:

  1. Pregnant or breastfeeding women, or women/men planning to conceive.
  2. Subjects who have had or are planned for major amputation (at or above the ankle level).
  3. 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.
  4. Subjects with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
  5. 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).
  6. Previously stented target lesion/vessel.
  7. Target lesion/vessel previously treated with drug-coated balloon <12 months prior to enrollment.
  8. Subjects with a life expectancy of less than 1 year.
  9. Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
  10. 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.
  11. Subjects currently participating in another clinical trial involving drugs or medical devices.
  12. Subjects whom the investigator considers unsuitable for participation in the clinical trial.

• Angiographic exclusion criteria:

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