This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.
Participants aged 18 to 80 years, regardless of sex;
Participants diagnosed with atherosclerotic disease of the common iliac or external iliac 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's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
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);
Single group
Peripheral Balloon-Expandable Covered Stent System
DeviceThe intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries.
primary patency
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Major Adverse Event
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death, myocardial infarction (MI), target lesion revascularization (TLR) or major amputation of the target limb.
Secondary Patency
The secondary patency of target lesion at 6, 12, 24, and 36 Months assessed by duplex ultrasound and adjudicated by an independent core laboratory
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