NCT00677235

Post-Approval Study for the FLAIR Endovascular Stent Graft

A Prospective, Randomized, Concurrently-Controlled Post-Approval Study of the FLAIR Endovascular Stent Graft

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Stenosis of Vascular Prosthetic Devices, Implants and Grafts

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2008-05-14
• Last updated: 2017-03-10
• Results posted: 2014-08-07

Locations

1 site across 1 country: United States