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

Exclusion Criteria

• •Pregnant or planning to become pregnant, or breastfeeding women;
• •Participants who have previously had a vascular graft implanted in the native iliac artery;
• •Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
• •Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (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 undergoing dialysis;
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;
• •Severe anemia (hemoglobin level \< 60.0 g/L);
• •Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;
• •Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;
• •Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;
• •Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a 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 participant unsuitable for the clinical trial.