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

This study is currently recruiting participants.
Verified January 2014 by Medtronic Endovascular
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00805948
First received: December 8, 2008
Last updated: January 7, 2014
Last verified: January 2014

December 8, 2008
January 7, 2014
January 2009
February 2019   (final data collection date for primary outcome measure)
Freedom from aneurysm-related mortality at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00805948 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Aortic Aneurysms
Device: Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aneurysms using the Talent Thoracic Stent Graft System.
Other Name: Talent Thoracic Stent Graft System
Experimental: Test Group
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.
Intervention: Device: Talent Thoracic Stent Graft System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
256
July 2019
February 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: P J Belmont 707-591-2520 pj.belmont@medtronic.com
United States
 
NCT00805948
Investigational Plan #109
No
Medtronic Endovascular
Medtronic Endovascular
Medtronic
Principal Investigator: Adam W Beck, MD University of Florida
Medtronic Endovascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP