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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.
 
ClinicalTrials.gov Identifier: NCT00805948
Recruitment Status : Terminated (Study device discontinued & insufficient sample size for statistical results.)
First Posted : December 10, 2008
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular

Tracking Information
First Submitted Date  ICMJE December 8, 2008
First Posted Date  ICMJE December 10, 2008
Results First Submitted Date  ICMJE September 19, 2017
Results First Posted Date  ICMJE August 14, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2008)
Freedom From Aneurysm-related Mortality at 5 Years [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2019)
  • 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.
  • 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)
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
Official Title  ICMJE Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thoracic Aortic Aneurysms
Intervention  ICMJE Device: Talent Thoracic Stent Graft System
endovascular repair of descending thoracic aortic aneurysms using the Talent Thoracic Stent Graft System.
Study Arms  ICMJE
  • Experimental: DeNovo
    Prospectively enrolled subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
    Intervention: Device: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
349
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
256
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00805948
Other Study ID Numbers  ICMJE Investigational Plan #109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Endovascular
Study Sponsor  ICMJE Medtronic Endovascular
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Adam W Beck, MD University of Florida
PRS Account Medtronic Endovascular
Verification Date July 2019

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