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

This study is currently recruiting participants.
Verified January 2013 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 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Thoracic Aortic Aneurysms
 Device: Talent Thoracic Stent Graft System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Freedom from aneurysm-related mortality at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 256
Study Start Date: January 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Patients diagnosed with a descending thoracic aortic aneurysm are considered candidates for the endovascular repair, per the FDA approved IFU.
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805948

Contacts
Contact: Amritpal Chohan, BS rs.medtroniccardiovascularclinicaltrials@medtronic.com

  Show 26 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00805948     History of Changes
Other Study ID Numbers: Investigational Plan #109
Study First Received: December 8, 2008
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
thoracic aneurysm
thoracic aortic aneurysms
TEVAR
Talent Thoracic Stent Graft

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on June 17, 2013