Clinical Trial: VALOR: The Talent Thoracic Stent Graft System Clinical Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms
Brief Summary: A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.
Detailed Summary:
Sponsor: Medtronic Endovascular
Current Primary Outcome:
- Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit. [ Time Frame: 12 months ]
- Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up. [ Time Frame: 12 months ]
Original Primary Outcome:
- Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
- Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medtronic Endovascular
Dates:
Date Received: December 21, 2007
Date Started: July 2003
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012
