Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE) (THRIVE)
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|ClinicalTrials.gov Identifier: NCT00805948|
Recruitment Status : Terminated (Study device discontinued & insufficient sample size for statistical results.)
First Posted : December 10, 2008
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysms||Device: Talent Thoracic Stent Graft System||Not Applicable|
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.)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||349 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)|
|Actual Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2017|
Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
Device: Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.
No Intervention: Valor
Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study
- Freedom From Aneurysm-related Mortality at 5 Years [ Time Frame: 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.
- All-Cause Mortality [ Time Frame: 1, 12, 24, 36, 48 and 60 months ]Number of subjects who died during that interval or who were followed at least until the lower endpoint of the analysis window.
- Number of Participants With Conversion to Surgery [ Time Frame: 1, 12, 24, 36, 48 and 60 months ]Conversion from endovascular to open repair required at the time of the original procedure or at the time beyond the initial endovascular procedure (for the same lesion treated during the initial implantation of the Talent Thoracic Stent Graft)
- Number of Participants With Aneurysm Rupture [ Time Frame: 1, 12, 24, 36, 48 and 60 months ]Rupture or perforation of the targeted aneurismal sac as detected by angiography, CT scan, or direct observation at surgery or autopsy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805948
|Principal Investigator:||Adam W Beck, MD||University of Florida|