Overview

This trial is active, not recruiting.

Condition thoracic aortic aneurysms
Treatment talent thoracic stent graft system
Phase phase 4
Sponsor Medtronic Endovascular
Collaborator Medtronic
Start date January 2009
End date January 2019
Trial size 256 participants
Trial identifier NCT00805948, Investigational Plan #109

Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients diagnosed with a descending thoracic aortic aneurysm are considered candidates for the endovascular repair. The Talent Thoracic Stent Graft System is compressed and pre-loaded into the delivery system,which is inserted endoluminally via the femoral or iliac artery and tracked through the patient's vasculature to deliver the stent graft to the target site.
talent thoracic stent graft system Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aneurysms using the Talent Thoracic Stent Graft System.

Primary Outcomes

Measure
Freedom from aneurysm-related mortality at 5 years
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: appropriate anatomy for elective repair of the descending thoracic aortic aneurysm - iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and or accessories - non-aneurysmal aortic diameter in the range of 18-42mm; and - non-aneurysmal aortic proximal and distal neck lengths equal to or greater than 20mm - subject has a Descending Fusiform Thoracic Aneurysm = to or greater than 5cm in diameter OR is = to or greater than 2 times the diameter of the non-aneurysmal thoracic aorta and/or saccular aneurysms/penetrating ulcers - Signed patient informed consent Exclusion Criteria: - Less than 18 yrs old - pregnant - unable to comply w/follow-up - participating in other drug or device trials; - Subject has a co-morbidity causing expected survival to be less than 1 year

Additional Information

Official title Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
Principal investigator Adam W Beck, MD
Description 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 clinical study the Talent Thoracic Stent Graft will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Medtronic Vascular submitted a Pre-Market Application (PMA P070007) to the FDA on February 28, 2007, and received market approval for the Talent Stent Graft System on June 5, 2008. As a condition of approval, the FDA has requested a post-market trial. In collaboration with the FDA, Medtronic has designed a post-approval study to document the long-term performance of the Talent Stent Graft System under post market conditions. This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective, non-randomized five-year trial. Originally, a total of 451 subjects were going to be analyzed. That group consisted of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 planned "de novo" subjects enrolled after the PMA approval. However, Medtronic discontinued manufacturing of the study device for US commercialization, and as a result, enrollment was terminated in May 2014, when it was determined that no more proximal devices were available either in inventory or at the sites. A total of 349 subjects will be analyzed, based on 195 VALOR Test Group subjects and 154 "de novo" subjects.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.