The primary objective of this study is to assess the safety and effectiveness of the Atrium iCAST ePTFE covered stent compared to a performance metric based upon the results of other FDA-approved iliac stents (Wallstent, SMART stent, Intrastent) in patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.
18 years of age or older.
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.
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.
Has angiographic evidence of a patent profunda or superficial femoral artery in the target limb.
Has provided written informed consent.
Is able and willing to adhere to the required follow-up visits and testing through month 36.
Is able and willing to adhere to the required follow-up medication regimen.
Presence of other non-target ipsilateral arterial lesions requiring treatment.
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.
Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion.
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.
Has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
Has a vascular graft previously implanted in the native iliac vessel.
Has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
Has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to stainless steel, ePTFE or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
History of neutropeniam coagulopathy, or thrombocytopenia that has not resolved or has required treatment in the past 6 months.
Known bleeding or hypercoagulability disorder or significant anemia that cannot be corrected.
Subject has the following laboratory values: a. platelet count less than 80,000/ µL, b. PT/PTT not within normal limits (as determined by individual center) c. serum creatinine level greater than 2.5 mg/dL
Requires general anesthesia for the procedure.
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..