CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 270 enrolled
Drug / intervention
FLAIR Endovascular Stent Graft +1 moredevice
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/NCT00677235
NCT00677235N/ACompleted
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A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

C. R. Bard·interventional·Posted May 14, 2008·Updated Mar 10, 2017

In Brief

A clinical study evaluating FLAIR Endovascular Stent Graft and PTA for Stenosis of Vascular Prosthetic Devices, Implants and Grafts. Completed, enrolled 270 participants across 1 site.

Detailed Summary

The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStenosis of Vascular Prosthetic Devices, Implants and Grafts
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 14, 2008
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 18.1 years ago

Interventions

FLAIR Endovascular Stent Graftdevice

Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft

PTAprocedure

Treatment of stenoses with PTA only