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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00805948
First received: December 8, 2008
Last updated: July 10, 2014
Last verified: July 2014
  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:


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: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Harbor-UCLA
Torrance, California, United States, 90502
United States, District of Columbia
Washington Hospital D.C.
Washington, DC, District of Columbia, United States, 20010
United States, Florida
U Florida at Shands Hospital
Gainesville, Florida, United States, 32610
Osceola Regional Med Ctr
Kissimmee, Florida, United States, 34741
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern MH
Chicago, Illinois, United States, 60611
Southern Illinois University
Springfield, Illinois, United States, 62702
United States, Indiana
St. Vincent Heart Center
Indianapolis, Indiana, United States, 46290
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Northshore University Hospital
Lake Success, New York, United States, 11042
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
University of Toledo Med Ctr
Toledo, Ohio, United States, 43615
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburg, Pennsylvania, United States, 15213
Pinnacle Health
Wormleysburg, Pennsylvania, United States, 17043
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Tennova Physicians Regional Medical Center
Powell, Tennessee, United States, 37849
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
The Heart Hospital/Baylor Plano
Plano, Texas, United States, 38120
United States, Virginia
Sentara Norfolk General Vascular & Transplant Specialists
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Providence Sacred Heart
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Medtronic Endovascular
Medtronic
Investigators
Principal Investigator: Adam W Beck, MD University of Florida
  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: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Endovascular:
thoracic aneurysm
thoracic aortic aneurysms
Thoracic Endovascular Aneurysm Repair (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 July 24, 2014