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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805948
Recruitment Status : Active, not recruiting
First Posted : December 10, 2008
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
Medtronic Endovascular

Brief 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.

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysms Device: Talent Thoracic Stent Graft System Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
Study Start Date : January 2009
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Freedom from aneurysm-related mortality at 5 years [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00805948

  Hide Study Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
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
Baylor College of Medicine
Houston, Texas, United States, 77030
The Methodist Hospital
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
Principal Investigator: Adam W Beck, MD University of Florida

Responsible Party: Medtronic Endovascular Identifier: NCT00805948     History of Changes
Other Study ID Numbers: Investigational Plan #109
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Medtronic Endovascular:
thoracic aneurysm
thoracic aortic aneurysms
Thoracic Endovascular Aneurysm Repair (TEVAR)
Talent Thoracic Stent Graft

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