NCT00678249

Pivotal Study for the FLAIR Endovascular Stent Graft

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A total of 227 patients were treated at 16 U.S. investigational sites to evaluate the safety and effectiveness of the FLAIR™ Endovascular Stent Graft. 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

Type	Name	Description
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.

Timeline

• Start date: 2001-01-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2008-05-15
• Last updated: 2011-05-11
• Results posted: 2011-05-09

Locations

1 site across 1 country: United States