CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 325 enrolled
Drug / intervention
SUPERA® Nitinol Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00933270
NCT00933270N/ACompleted
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Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

Abbott Medical Devices·interventional·Posted Jul 7, 2009·Updated May 30, 2017

In Brief

A clinical study evaluating SUPERA® Nitinol Stent System for Peripheral Vascular Disease. Completed, enrolled 325 participants across 49 sites.

Detailed Summary

This is a prospective, multicenter, non-randomized, single arm, pivotal trial. The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Disease
CountriesUnited States
CollaboratorsBaim Institute for Clinical Research

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2009
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.0 years ago

Interventions

SUPERA® Nitinol Stent Systemdevice

Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA