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Pivotal Study for the FLAIR Endovascular Stent Graft

NCT00678249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2011-05-11

Study results available
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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.

Conditions

  • Stenoses

Interventions

DEVICE

FLAIR Endovascular Stent Graft

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

PROCEDURE

PTA

Percutaneous Transluminal Angioplasty

DEVICE

FLAIR Endovascular Stent Graft

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.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • David Ciavarella, MD · C. R. Bard

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2004-06-30
Completion
2004-06-30

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 NCT00678249 on ClinicalTrials.gov