CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 227 enrolled
Drug / intervention
FLAIR Endovascular Stent Graft +2 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/NCT00678249
NCT00678249N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Randomized Evaluation of an IMPRA/Bard ePTFE Encapsulated Carbon Lined Nitinol Endoluminal Device for AV Access Graft Stenoses

C. R. Bard·interventional·Posted May 15, 2008·Updated May 11, 2011

In Brief

A clinical study evaluating FLAIR Endovascular Stent Graft and PTA for Stenoses. Completed, enrolled 227 participants across 1 site.

Detailed Summary

This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStenoses
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartJan 1, 2001
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.1 years ago

Interventions

FLAIR Endovascular Stent Graftdevice

Primary balloon angioplasty followed by placement of the FLAIR Endovascular Stent Graft

PTAprocedure

Percutaneous Transluminal Angioplasty

FLAIR Endovascular Stent Graftdevice

Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.