Status:
WITHDRAWN
Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Baim Institute for Clinical Research
Conditions:
With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, multicenter, non-randomized, single-arm trial; the primary objective is to assess the comparability of the performance of the IDev SUPERA® nitinol stent to a rate derived from a...
Eligibility Criteria
Inclusion
- Subject is 18 years of age or older and of legal age of consent.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
- Subject has de novo or restenotic lesions in the common 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 4 and 10 mm in diameter and less than 110 mm in length.
- Subject has angiographic evidence of a patent femoral outflow artery 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
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Exclusion
- Presence of other non-target arterial lesions requiring treatment within 30 days of the procedure.
- The target lesion(s) has adjacent, acute thrombus.
- The target lesion(s) is highly calcified or was previously treated with a stent.
- Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
- Subject has an abdominal aortic aneurysm contiguous with the iliac artery target lesion. Subject has a pre-existing aneurysm or dissection of the target iliac segment.
- Subject with aortic or iliac aneurysm that is likely to require repair within the next 9 months.
- 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 is unable to accommodate ≥ 7 Fr cat
- Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has a hypersensitivity to nickel, or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
- Subject has history of neutropenia (WBC \<3,000/mm3).
- Subject has coagulopathy or thrombocytopenia (platelet count \<80,000/ μL) that has not resolved or has required treatment in the past 6 months.
- Subject has known bleeding or hypercoagulability disorder or significant anemia (Hb \< 8.0 g/dL) that cannot be corrected.
- Subject has the following laboratory values:
- international normalized ratio (INR) greater than 1.5,
- serum creatinine level greater than 2.5 mg/dL.
- Subject requires general anesthesia for the procedure.
- Subject is pregnant or plans to become pregnant during the study.
- 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.
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Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00613418
Start Date
January 1 2019
End Date
January 1 2019
Last Update
May 9 2019
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