Post-Approval Study for the FLAIR Endovascular Stent Graft

2014-08-27 03:30:39 | BioPortfolio


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.


The purpose of the study is to compare efficacy data on subjects randomized to treatment with percutaneous transluminal angioplasty (PTA) and the FLAIR™ Endovascular Stent Graft versus subjects randomized to treatment with PTA only.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Stenosis of Vascular Prosthesis


FLAIR Endovascular Stent Graft, PTA


Access Connections
South Carolina
United States




C. R. Bard

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:30:39-0400

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