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

Inclusion Criteria:

• (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limbischemia defined as Rutherford categories 2, 3, 4 or 5. (3) Subject (or legalguardian, if applicable) is willing and able to provide consent before to theperformance of any study specific tests or procedures, has signed the consent formand agrees to attend all required follow-up visits.

Angiographic Inclusion Criteria:

Eligible subjects must meet all of the following angiographic criteria:

1. Stenotic, restenotic or occlusive lesion(s) located in the native superficialfemoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e., within the P1segment):

2. Degree of stenosis ≥70% by visual angiographic assessment.

3. Vessel diameter ≥4.0 mm and ≤6.5 mm.

4. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesionsegment(s) must be fully covered with one stent).

5. Chronic total occlusion with a total lesion length of ≤120 mm.

6. 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:

Subjects will be excluded from the study if any of the following conditions are present:

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 anklelevel).

3. Subjects known to be allergic or intolerant to materials used in the investigationaldevice 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 coagulationdysfunction (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 toenrollment.

8. Subjects with a life expectancy of less than 1 year.

9. Subjects who have received local or systemic thrombolysis treatment within 48 hoursprior to enrollment.

10. Subjects diagnosed with major clinical diseases or unstable conditions within thepast 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 intravascularcoagulation.

11. Subjects currently participating in another clinical trial involving drugs ormedical devices.

12. Subjects whom the investigator considers unsuitable for participation in theclinical 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 debulkingdevices that may damage the vessel intima.

4. The guidewire cannot pass through the target lesion, or percutaneous transluminalangioplasty (PTA) balloon cannot be used for pre-dilation.

5. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment.