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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Sponsor: W.L.Gore & Associates
Summary
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2019-06-17
Completion Date
2030-01
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Locations (44)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
MedStar Health Research Institute - MedStar Washington Hospital
Washington D.C., District of Columbia, United States
University of Florida - Gainesville
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan - Cardiac Surgery
Ann Arbor, Michigan, United States
Essentia Health
Duluth, Minnesota, United States
Division of Vascular Surgery - Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Mount Sinai West
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPP Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States
University of Tennessee -University Vascular Surgeons
Knoxville, Tennessee, United States
St. David's Healthcare
Austin, Texas, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The Methodist Hospital - Houston
Houston, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
Carilion Clinic Hospitals
Roanoke, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
St. Mary's Hospital, Imperial College Healthcare, NHS Trust
London, United Kingdom