Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery (I-WIN)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Harvard Clinical Research Institute
Information provided by (Responsible Party):
IDev Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00613418
First received: January 30, 2008
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 meta-analysis of studies on iliac stents approved by FDA for treating subjects with de novo or restenotic lesions in the common and/or external iliac arteries.


Condition Intervention Phase
With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries.
Device: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Safety and Efficacy of the SUPERA® Wire Interwoven Self-expanding Nitinol Stent and Currently Approved Stents for Patients With Iliac Lesions

Further study details as provided by IDev Technologies, Inc.:

Primary Outcome Measures:
  • Occurrence of death [ Time Frame: within 30 days post-procedure ] [ Designated as safety issue: Yes ]
  • Target site revascularization or restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse events (MAEs) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Device success (delivery and deployment of the study stent and retrieval of the delivery system) [ Time Frame: During implantation procedure ] [ Designated as safety issue: Yes ]
  • Acute procedural success [ Time Frame: immediately following stent deployment ] [ Designated as safety issue: Yes ]
  • Early and late clinical success (Rutherford-Becker improvement); ABI and TBI improvement; symptom based. [ Time Frame: 30 days and 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel patency [ Time Frame: 6, 9, 12, 24, and 36 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
single
Historical control
Device: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System
Interwoven, self-expanding nitinol stent system, including delivery system and stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 18 years of age or older and of legal age of consent.
  2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
  3. Subject has de novo or restenotic lesions in the common or external iliac artery.
  4. Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
  5. The target lesion(s) can be successfully crossed with a guide wire and dilated.
  6. The target segment of subject's lesion(s) is between 4 and 10 mm in diameter and less than 110 mm in length.
  7. Subject has angiographic evidence of a patent femoral outflow artery in the target limb.
  8. Subject has provided written informed consent.
  9. Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
  10. Subject is able and willing to adhere to the required follow-up medication regimen

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Exclusion Criteria:

  1. Presence of other non-target arterial lesions requiring treatment within 30 days of the procedure.
  2. The target lesion(s) has adjacent, acute thrombus.
  3. The target lesion(s) is highly calcified or was previously treated with a stent.
  4. Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
  5. 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.
  6. Subject with aortic or iliac aneurysm that is likely to require repair within the next 9 months.
  7. Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
  8. Subject has a vascular graft previously implanted in the native iliac vessel.
  9. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
  10. Subject is unable to accommodate ≥ 7 Fr cat
  11. 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.
  12. Subject has history of neutropenia (WBC <3,000/mm3).
  13. Subject has coagulopathy or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
  14. Subject has known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected.
  15. Subject has the following laboratory values:

    1. international normalized ratio (INR) greater than 1.5,
    2. serum creatinine level greater than 2.5 mg/dL.
  16. Subject requires general anesthesia for the procedure.
  17. Subject is pregnant or plans to become pregnant during the study.
  18. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
  19. 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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: IDev Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00613418     History of Changes
Other Study ID Numbers: I-1 - US
Study First Received: January 30, 2008
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014