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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/8/2017
Start Date:January 2009
End Date:July 2019

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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.

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.

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
We found this trial at
26
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Albany, New York 12208
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Chattanooga, Tennessee 37404
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Chicago, Illinois 60611
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Gainesville, Florida 32610
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Houston, Texas 77030
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Indianapolis, Indiana 46290
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Kissimmee, Florida 34741
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Lake Success, New York 11042
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Memphis, Tennessee 38120
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Norfolk, VA
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Pittsburg, Pennsylvania 15213
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Plano, Texas 75093
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Powell, TN
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Spokane, Washington 99204
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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Toledo, OH
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Torrance, California 90502
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Washington, DC, District of Columbia 20010
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Wormleysburg, Pennsylvania 17043
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