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Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms — VITALITY  

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
Endovascular Repair Using the Talent™ Abdominal Stent Graft System in Abdominal Aortic Aneurysms (VITALITY)

Clinical Trial Summary

The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.

Clinical Trial Description

The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies. Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug Administration (FDA) on October 17, 2007, and received market approval for the Talent Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has requested a post-approval study. Medtronic has therefore designed a post-approval study, in collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft System under market conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00816062
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Completed
Phase N/A
Start date December 2008
Completion date July 2015
View Details
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