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Pivotal Study for the FLAIR Endovascular Stent Graft

2014-08-27 03:30:38 | BioPortfolio

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.

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.

Study Design

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

Conditions

Stenoses

Intervention

FLAIR Endovascular Stent Graft, PTA

Location

New York Presbyterian Hospital/Columbia
New York
New York
United States
10032

Status

Completed

Source

C. R. Bard

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:38-0400

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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 immune responses of a host to a graft. A specific response is GRAFT REJECTION.

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The induction of prolonged survival and growth of allografts of either tumors or normal tissues which would ordinarily be rejected. It may be induced passively by introducing graft-specific antibodies from previously immunized donors, which bind to the graft's surface antigens, masking them from recognition by T-cells; or actively by prior immunization of the recipient with graft antigens which evoke specific antibodies and form antigen-antibody complexes which bind to the antigen receptor sites of the T-cells and block their cytotoxic activity.

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