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:

• 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.
• A major adverse event (MAE) is defined as a composite rate of MAVE or any death, or stroke, up to 30 days post-procedure.
• Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
• 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.
• Clinical success, assessed both early (30 days) and late (6, 9 and 12 months).
• Patency assessed at each follow-up time point, categorized as primary, primary-assisted or secondary patency.
• 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.

Inclusion criteria

• Subject is 18 years of age or older.
• Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4).
• Presence of de novo and/or restenotic lesions in the common and/or external iliac artery.
• Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length.
• Subject has angiographic evidence of a patent profunda or superficial femoral artery (SFA) in the target limb.
• Subject has provided written informed consent.
• Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
• Subject is able and willing to adhere to the required follow-up medication regimen.

Exclusion criteria

• Presence of other non-target ipsilateral arterial lesions requiring treatment within 30 days post-procedure (Note that treatment of ipsilateral SFA lesions may be allowed under certain circumstances). Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment.
• The target lesion(s) has adjacent, acute thrombus.
• The target lesion(s) is highly calcified or was previously treated with a stent.
• Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. "jailing" of the side-branch).
• Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
• Subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to initiation of the iCAST implant procedure.
• Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
• Subject has a vascular graft previously implanted in the native iliac vessel.
• Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
• Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
• History of neutropenia (WBC <3,000/mm3), coagulopathy, or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
• Known bleeding or hypercoagulability disorder or significant anemia (Hb< 8.0) that cannot be corrected.
• Subject has the following laboratory values:

• platelet count less than 80,000/ μL,
• prothrombin time (PT)/partial thromboplastin time (PTT) not within normal limits
• serum creatinine level greater than 2.5 mg/dL
• Subject requires general anesthesia for the procedure.
• Subject is pregnant.
• Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
• Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.