Atrium iCAST Iliac Stent Pivotal Study

Completed · Not applicable

Conditions studied: Peripheral Vascular Disease

In brief

Prospective, multicenter, non-randomized, single-arm registry to evaluate the safety and effectiveness of the iCAST Covered Stent System in the treatment of patients with symptomatic claudication or rest pain and angiographic confirmation of de novo or restenotic lesions in the common and/or external iliac artery.

Key facts

Study ID

NCT00593385

Run by

Atrium Medical Corporation

People needed

165

Starts

2007-10-01

Expected to finish

2014-05-01

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Fogarty Clincal Research Incorporated — Mountain View, California, United States
• University of California, Davis — Sacramento, California, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Piedmont Hospital Research Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Krannert Institute of Cardiology — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Terrebonne General Medical Center — Houma, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mass General Hospital — Boston, Massachusetts, United States
• Forest General Hospital — Hattiesburg, Mississippi, United States
• Kansas City Heart Foundation — Kansas City, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• University Hospitals, Case Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• MidWest Cardiology Research Foundation — Columbus, Ohio, United States
• Holy Spirit Cardiovascular Institute — Camp Hill, Pennsylvania, United States
• North Central Heart Institute — Sioux Falls, South Dakota, United States
• Tennova Healthcare - Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Cardiovascular Research Institute of Dallas — Dallas, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• Herzzentrum Bad Krozingen — Bad Krozingen, Germany

Full record on ClinicalTrials.gov

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