Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00805948 |
| Other study ID # |
Investigational Plan #109 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2009 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
September 2021 |
| Source |
Medtronic Cardiovascular |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.)
