Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

Not Applicable

Terminated

Conditions: Thoracic Aortic Aneurysms

Registration Number: NCT00805948

Lead Sponsor: Medtronic Cardiovascular

Brief 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.

Detailed 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.

Update as of Aug 2017: Medtronic Vascular, Inc. discontinued manufacture of the Talent Thoracic Stet Graft System on 31-Jul-2012, and the final device expired in July 2014 (based on the two-year shelf life). Enrollment for De Novo subjects ended in May 2014, as there were no more proximal main devices available either in inventory or at the investigational sites. This resulted in a total of 349 subjects to be analyzed in this final report: the 195 VALOR subjects and 154 of the planned 256 De Novo subjects. Because of that, statistical results would have been inconclusive, so Medtronic decided to terminate the study and received FDA approval for early termination in April 2016.

It is important to emphasize that THRIVE subjects will continue to be followed-up annually per standard of care and standard post-market surveillance program applies to them (e.g. device complaints will continue to be reported via the MDR (Medical Device Reporting) system.)

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 349

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom From Aneurysm-related Mortality at 5 Years	5 years	For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (26): Cedars Sinai Medical Center
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Los Angeles, California, United States
Harbor-UCLA
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Torrance, California, United States
Washington Hospital D.C.
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Washington, District of Columbia, United States
U Florida at Shands Hospital
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Gainesville, Florida, United States
Osceola Regional Med Ctr
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Kissimmee, Florida, United States
Emory University
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Atlanta, Georgia, United States
Northwestern MH
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Chicago, Illinois, United States
Southern Illinois University
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Springfield, Illinois, United States
St. Vincent Heart Center
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Indianapolis, Indiana, United States
Brigham & Women's Hospital
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Boston, Massachusetts, United States
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Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States