NCT00413231

Valor II: The Valiant Thoracic Stent Graft System Clinical Study

The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

Detailed description

The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.

Conditions

• Thoracic Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Valiant Thoracic Stent Graft System	Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-08-01
• Completion: 2014-10-01
• First posted: 2006-12-19
• Last updated: 2021-11-03
• Results posted: 2012-04-05

Locations

26 sites across 1 country: United States