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

NCT00613418 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-09

No results posted yet for this study

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

Interventions

DEVICE

IDev SUPERA® Interwoven Self Expanding Nitinol Stent Peripheral Vascular System

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

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-01-01
Completion
2019-01-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613418 on ClinicalTrials.gov