NCT00604799|CompletedPhase 2/3DMC
VALOR: The Talent Thoracic Stent Graft System Clinical Study
VALOR
Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms
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Sponsor study identifier
interventional
379
1 country
1
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
June 2011
Actual (reported)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 Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
June 2006
Actual (reported)December 21, 2007
Actual (reported)January 30, 2008
Actual (reported)June 2011
Actual (reported)Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.
12 months
Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.
12 months
Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, \& 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery \& 20 mm proximal to the origin of the celiac artery.
Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.
TEVAR
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Mark Kaye, MD
Physician's Regional Medical Center
Phillip Allmendinger, MD
Hartford Hospital
Mark Bates, MD
CAMC Health System
Daniel Benckart, MD
West Penn Allegheny Health System
379 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2007
First Posted
January 30, 2008
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Valiant Evo US Clinical Trial
Patients that meet one or more of the following: * High Risk (SVS 3) * Non-surgical candidates not associated with SVS scoring * Traumatic thoracic injuries
Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.
Contact the study team to confirm eligibility.
Paul Bove, MD
Corewell Health East
Thomas Bower, MD
Mayo Clinic
Alfio Carroccio, MD
Mt. Sinai School of Medicine
Neal Cayne, MD
NYU Vascular Associates
Frank Criado, MD
Union Memorial Hospital
Alan Matsumoto, MD
University of Virginia
Mark Eskandari, MD
Northwestern Memorial Hospital
Ronald Fairman, MD
University of Pennsylvania
Mark Farber, MD
University of North Carolina
James McKinsey, MD
New York Presbyterian (Columbia & Cornell)
Mark Fillinger, MD
Dartmouth-Hitchcock Medical Center
H. Edward Garrett, MD
Baptist Memorial Hospital
Marc Glickman, MD
Sentar Norfolk General
Kim Hodgson, MD
Memorial Medical Center
Matthew Jung, MD
Surgical Care Associates
Barry Katzen, MD
Baptist Health South Florida
Zvonimir Krajcer, MD
St. Luke's Episcopal Hospital-Houston
Christopher Kwolek, MD
Massachusetts General Hospital
Lowell Satler, MD
Medstar Health Research Institute
Anthony Lee, MD
University of Florida
Alan Lumsden, MD
Baylor College of Medicine
Sean Lyden, MD
Cleveland Clinic Foundation-Ohio
Richard McCann, MD
Duke University
Manish Mehta, MD
Vascular Group, PLLC
Mark Mewissen, MD
St. Luke's Vascular Center
Takao Ohki, MD
Montefiore Medical Center
Venkatesh Ramaiah, MD
Arizona Heart Institute
Robert Rhee, MD
Shadyside Hospital-UPMC
Timothy Roush, MD
Carolinas Medical Center
Gregoria Sicard, MD
Washington University School of Medicine
Cary Stowe, MD
AdventHealth
Jim Swischuk, MD
Saint Francis Hospital
Michael Tuchek, MD
Loyola University
Rodney White, MD
Harbor UCLA
David Williams, MD
University of Michigan
Christopher Zarins, MD
Stanford University
Primary Completion
June 2006
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
November 2, 2021
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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