Atrium iCAST Iliac Stent Pivotal Study

STUDY DESIGN: Prospective, multicenter, non-randomized, single-arm registry OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries. NUMBER OF SUBJECTS: 165 subjects, including up to 25 subjects with totally occluded lesions. PRIMARY ENDPOINTS: The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization or restenosis (by ultrasound determination) within 9 months post-procedure. SECONDARY ENDPOINTS: Secondary endpoints include: 1. Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene), arterial rupture, acute limb ischemia, target limb amputation or procedure related bleeding event requiring transfusion. 2. A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure. 3. Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. 4. Acute procedural success, defined as device success and achievement of \< 30% residual stenosis immediately after stent deployment, mean transtenotic pressure gradient of \< 5 mmHg and without occurrence of in-hospital MAVE. 5. Clinical success, assessed both early (30 days) and late (6, 9 and 12 months). 6. Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency. 7. Composite rate of 30 day death, 9 month target site revascularization and 9 month restenosis in subjects without iliac total occlusions. PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery.