NCT01213589

The VIRTUE Post Marketing Surveillance Registry

The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.

Detailed description

The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005. The Medtronic VALIANT Thoracic Stent Graft with Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors. This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection. For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed. This is a descriptive registry in which no specific hypotheses will be statistically tested.

Conditions

• Aortic Dissection

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-10-04
• Last updated: 2013-12-11
• Results posted: 2013-12-11