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Post-Approval Study for the FLAIR Endovascular Stent Graft

NCT00677235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2017-03-10

Study results available
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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.

Conditions

  • Stenosis of Vascular Prosthetic Devices, Implants and Grafts

Interventions

DEVICE

FLAIR Endovascular Stent Graft

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

PROCEDURE

PTA

Treatment of stenoses with PTA only

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Ziv Haskal, MD · University of Maryland Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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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 NCT00677235 on ClinicalTrials.gov