Clinical trial NCT00805948: Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
Official title: Descending Thoracic Aortic Aneurysm Endovascular Repair Post-approval Study (THRIVE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thoracic Aortic Aneurysms
Keywords: thoracic aneurysm
thoracic aortic aneurysms
Thoracic Endovascular Aneurysm Repair (TEVAR)
Talent Thoracic Stent Graft
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2008-12-10
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

Eligibility 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

Primary outcomes:
measure: Freedom From Aneurysm-related Mortality at 5 Years
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: All-Cause Mortality
timeFrame: 1, 12, 24, 36, 48 and 60 months
measure: Number of Participants With Conversion to Surgery
timeFrame: 1, 12, 24, 36, 48 and 60 months
measure: Number of Participants With Aneurysm Rupture
timeFrame: 1, 12, 24, 36, 48 and 60 months
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA
state: California
city: Washington
country: United States
facility: Washington Hospital D.C.
state: District of Columbia
city: Gainesville
country: United States
facility: U Florida at Shands Hospital
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Med Ctr
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern MH
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health Inc
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Med Ctr
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Powell
country: United States
facility: Tennova Physicians Regional Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital/Baylor Plano
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Vascular & Transplant Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart
state: Washington
Study officials:
affiliation: University of Florida
name: Adam W Beck, MD
role: PRINCIPAL_INVESTIGATOR
References: