Comparative Study Of Safety And Efficacy Of The SUPERA® Nitinol Stent - Iliac Artery

NCT00613418 | Withdrawn DMC FDA Device

• 1 other identifier: I-1 - US
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

With de Novo or Restenotic Lesions in the Common and/or External Iliac Arteries

Outcome Measures

Primary Outcomes (2)

• Occurrence of death

  within 30 days post-procedure

• Target site revascularization or restenosis

  9 months

Secondary Outcomes (6)

• 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

Study Arms (1)

single

OTHER

Historical control

Device: IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System

Interventions

IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System DEVICE

Interwoven, self-expanding nitinol stent system, including delivery system and stent

single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Baim Institute for Clinical Research: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05