Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)

Inclusion Criteria:

• Participants aged 18 to 80 years, regardless of sex;

• Participants diagnosed with atherosclerotic disease of the common iliac or externaliliac artery;

• Participants with a Rutherford classification of 2 to 4 for the target limb;

• Participants or their legal representatives must be able to understand the study'spurpose, demonstrate adequate compliance with the study protocol, and sign theinformed consent form.

Exclusion Criteria:

• Pregnant or planning to become pregnant, or breastfeeding women;

• Participants who have previously had a vascular graft implanted in the native iliacartery;

• Participants who have had a stroke or myocardial infarction within 3 months prior toenrollment;

• Participants with known uncorrectable bleeding disorders or severe coagulationabnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count < 80×10^9/L);

• Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoingdialysis;

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times theupper limit of normal;

• Severe anemia (hemoglobin level < 60.0 g/L);

• Participants known to be allergic or intolerant to cobalt-based alloys, expandedpolytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban,paclitaxel, contrast agents, or other study materials and medications;

• Participants who have undergone vascular intervention within 30 days prior tosurgery or who plan to undergo vascular intervention within 30 days followingsurgery;

• Participants who have received intra-arterial thrombolysis treatment in the targetvessel within 14 days prior to enrollment;

• Participants with significant organ dysfunction or other severe conditions that maylead to non-compliance with the study protocol, affect data interpretation, or havea life expectancy insufficient to complete the clinical trial;

• Participants currently involved in a clinical trial of investigational drugs,biologics, or medical devices;

• Other conditions that, in the investigator's opinion, make the participantunsuitable for the clinical trial.