VALOR: The Talent Thoracic Stent Graft System Clinical Study

Phase 2

Completed

• Conditions: Thoracic Aortic Aneurysms
• Interventions: Device: Talent Thoracic Stent Graft

• Registration Number: NCT00604799
• Lead Sponsor: Medtronic Cardiovascular

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 Description

Not available

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2006-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-30
• Study Completion: 2011-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Talent Captivia (Recruiting)	Talent Thoracic Stent Graft	Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.
High Risk (Enrollment Completed)	Talent Thoracic Stent Graft	Patients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries
Test (Enrollment Completed)	Talent Thoracic Stent Graft	Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery.
Registry (Enrollment Completed)	Talent Thoracic Stent Graft	Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.	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.	12 months

Trial Locations

Locations (1)

University of Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States