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Post-Approval Study for the FLAIR Endovascular Stent Graft

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

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.

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.

Study Design

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

Conditions

Stenosis of Vascular Prosthesis

Intervention

FLAIR Endovascular Stent Graft, PTA

Location

Access Connections
Bamberg
South Carolina
United States
29003

Status

Recruiting

Source

C. R. Bard

Results (where available)

View Results

Links

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

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Medical and Biotech [MESH] Definitions

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

Obstruction of flow in biological or prosthetic vascular grafts.

Obstruction of the flow in the SPLANCHNIC CIRCULATION by ATHEROSCLEROSIS; EMBOLISM; THROMBOSIS; STENOSIS; TRAUMA; and compression or intrinsic pressure from adjacent tumors. Rare causes are drugs, intestinal parasites, and vascular immunoinflammatory diseases such as PERIARTERITIS NODOSA and THROMBOANGIITIS OBLITERANS. (From Juergens et al., Peripheral Vascular Diseases, 5th ed, pp295-6)

Products used to seal the openings in BLOOD VESSELS from incisions or punctures made during ENDOVASCULAR PROCEDURES.

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