I-WIN: Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery
Study Details
Study Description
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 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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
|
Outcome Measures
Primary Outcome Measures
- Occurrence of death [within 30 days post-procedure]
- Target site revascularization or restenosis [9 months]
Secondary Outcome Measures
- Major adverse events (MAEs) [30 days]
- Device success (delivery and deployment of the study stent and retrieval of the delivery system) [During implantation procedure]
- Acute procedural success [immediately following stent deployment]
- Early and late clinical success (Rutherford-Becker improvement); ABI and TBI improvement; symptom based. [30 days and 6, 9, and 12 months]
- Target vessel patency [6, 9, 12, 24, and 36 months]
- Quality of Life questionnaire [baseline, 3 and 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 18 years of age or older and of legal age of consent.
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Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2, 3 or 4).
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Subject has de novo or restenotic lesions in the common or external iliac artery.
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Subject has single, bilateral or multiple target lesions that is (are) ≥ 50% stenosed by visual estimate.
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The target lesion(s) can be successfully crossed with a guide wire and dilated.
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The target segment of subject's lesion(s) is between 4 and 10 mm in diameter and less than 110 mm in length.
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Subject has angiographic evidence of a patent femoral outflow artery in the target limb.
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Subject has provided written informed consent.
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Subject is able and willing to adhere to the required follow-up visits and testing through month 36.
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Subject is able and willing to adhere to the required follow-up medication regimen
Exclusion Criteria:
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Presence of other non-target arterial lesions requiring treatment within 30 days of the procedure.
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The target lesion(s) has adjacent, acute thrombus.
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The target lesion(s) is highly calcified or was previously treated with a stent.
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Subject has a pre-existing target iliac artery perforation or dissection of the target iliac artery prior to initiation of the IDev implant procedure.
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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.
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Subject with aortic or iliac aneurysm that is likely to require repair within the next 9 months.
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Subject has a post-surgical stenosis and anastomotic suture treatments of the target vessel.
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Subject has a vascular graft previously implanted in the native iliac vessel.
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Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
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Subject is unable to accommodate ≥ 7 Fr cat
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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.
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Subject has history of neutropenia (WBC <3,000/mm3).
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Subject has coagulopathy or thrombocytopenia (platelet count <80,000/ μL) that has not resolved or has required treatment in the past 6 months.
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Subject has known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0 g/dL) that cannot be corrected.
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Subject has the following laboratory values:
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international normalized ratio (INR) greater than 1.5,
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serum creatinine level greater than 2.5 mg/dL.
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Subject requires general anesthesia for the procedure.
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Subject is pregnant or plans to become pregnant during the study.
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Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Abbott Medical Devices
- Baim Institute for Clinical Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I-1 - US