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

September 23, 2021 updated by: Medtronic Cardiovascular

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

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.)

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Torrance, California, United States, 90502
        • Harbor-UCLA
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital D.C.
    • Florida
      • Gainesville, Florida, United States, 32610
        • U Florida at Shands Hospital
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Med Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern MH
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Heart Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Great Neck, New York, United States, 11021
        • Northwell Health Inc
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Toledo, Ohio, United States, 43615
        • University of Toledo Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Powell, Tennessee, United States, 37849
        • Tennova Physicians Regional Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Plano, Texas, United States, 38120
        • The Heart Hospital/Baylor Plano
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Vascular & Transplant Specialists
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DeNovo
Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
Device: Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.
No Intervention: Valor
Historical control arm, consisting of 195 subjects from the VALOR Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. The data from these subjects will be combined with the data from the subjects implanted after commercial release (DeNovo) to comprise the final analysis cohort for the THRIVE Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Aneurysm-related Mortality at 5 Years
Time Frame: 5 years
For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 1, 12, 24, 36, 48 and 60 months
Number of subjects who died during that interval or who were followed at least until the lower endpoint of the analysis window.
1, 12, 24, 36, 48 and 60 months
Number of Participants With Conversion to Surgery
Time Frame: 1, 12, 24, 36, 48 and 60 months
Conversion from endovascular to open repair required at the time of the original procedure or at the time beyond the initial endovascular procedure (for the same lesion treated during the initial implantation of the Talent Thoracic Stent Graft)
1, 12, 24, 36, 48 and 60 months
Number of Participants With Aneurysm Rupture
Time Frame: 1, 12, 24, 36, 48 and 60 months
Rupture or perforation of the targeted aneurismal sac as detected by angiography, CT scan, or direct observation at surgery or autopsy.
1, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Collaborators

Medtronic

Investigators

  • Principal Investigator: Adam W Beck, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Investigational Plan #109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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