Clinical Trial: Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of 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 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.

Sponsor: Medtronic Endovascular

Current Primary Outcome: Aneurysm-related Mortality (ARM) [ Time Frame: 5 year KM ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medtronic Endovascular

Dates:
Date Received: December 29, 2008
Date Started: December 2008
Date Completion:
Last Updated: January 27, 2016
Last Verified: January 2016