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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Peripheral Arterial Disease / Stent
Title   Atrium iCAST Iliac Stent Pivotal Study (Peripheral Arterial Disease / Stent)
Description   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.
IRB Number   Pro0006
Inclusion/Notes   INCLUSION:
  • 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.

EXCLUSION:
  • 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.

  • 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..
Status   Active - not Recruiting
Location   Texas Health Dallas
Principal Name    Kenneth Edward Saland MD
Contact Name   Angelia Hannah
Phone   (469) 916-7809

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