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General |
Study Status |
Terminated |
Application Number / Requirement Number |
P070007 / PAS001 |
Date Original Protocol Accepted |
06/05/2008
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Date Current Protocol Accepted |
04/05/2016
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Study Name |
THRIVE Trial
|
Device Name |
TALENT THORACIC STENT GRAFT SYSTEM
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This study will examine the post-market performance of the Talent Thoracic Stent Graft System. This study is a prospective non-randomized 5 year trial. A total of 451 subjects will be analyzed that consists of 195 enrolled subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 new subjects to be enrolled following PMA approval.
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Study Population |
For purposes of cohort comparability, the inclusion/exclusion criteria will match to those used for the VALOR study with the exception of the removal of the following two parameters from the exclusion criteria: the patient's access vessel (as determined by treating physician) precludes safe insertion of the delivery system and patient requires a planned aortic conduit. Patients diagnosed with a descending thoracic aortic aneurysm are considered candidates for the endovascular repair. ,
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Sample Size |
195 subjects from the VALOR Test Group of the Talent Thoracic PMA Submission, and 256 new implants, 26 sites
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Key Study Endpoints |
The primary endpoint of this study is freedom from aneurysm-related mortality at 5 years. The postmarket performance of the Talent Thoracic Stent Graft System will be evaluated by comparing aneurysm-related mortality rates in patients implanted with the Talent Stent Graft System at 5 years versus the rate at 1 year for open surgery. The open surgery aneurysm-related mortality rate is based on the experience collected in 3 Centers of Excellence. Aneurysm-related mortality is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the descending thoracic aorta
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Follow-up Visits and Length of Follow-up |
The planned follow-up is 5 years for #2002-07. Participants from the #99-03 study will be followed until the termination of the post-approval study.
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