Phase
Condition
Aneurysm
Heart Disease
Cardiovascular Disease
Treatment
GORE® TAG® Thoracic Branch Endoprosthesis
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Presence of thoracic aortic pathology deemed to warrant surgical repair whichrequires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone.
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aorticlanding zone.
Exclusion
Exclusion Criteria:
Concomitant disease of the ascending aorta or aneurysm of the abdominal aortarequiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery forAscending Aortic Dissection and/or placement of vascular conduit for access
Infected aorta
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
Stroke within 6 weeks prior to treatment, stroke defined as rapidly developingclinical signs of focal (or global) disturbance of cerebral function, lasting morethan 24 hours or leading to death, with no apparent cause other than that ofvascular origin.
Patient has a systemic infection and may be at increased risk of endovascular graftinfection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of studyenrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic archor ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheathinsertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrastmedia, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or knownhypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulabilitystate
Diameter taper outside of the device sizing range between proximal and distallanding zones of aorta and the inability to use additional devices of differentdiameters to compensate for the taper
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequatevisualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Arizona Heart Institute
Phoenix, Arizona 85006
United StatesSite Not Available
Cedar-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Keck Medical Center of USC
Los Angeles, California 90033
United StatesSite Not Available
Leland Stanford Junior University
Stanford, California 94305-5407
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06106
United StatesSite Not Available
MedStar Health Research Institute
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Health Research Institute
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
University of Florida - Gainesville
Gainesville, Florida 32610
United StatesSite Not Available
Univeristy of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
St. Vincent Medical Group, Inc.
Indianapolis, Indiana 46290
United StatesSite Not Available
University of Louisville Jewish Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
University or Maryland Baltimore
Baltimore, Maryland 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United StatesSite Not Available
Cooper University Hospital
Camden, New Jersey 08103
United StatesSite Not Available
Research Foundation SUNY Buffalo
Buffalo, New York 14203
United StatesSite Not Available
Carolinas HealthCare Systems
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Cardiovascular Surgery Clinic
Memphis, Tennessee 38120
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Cardiothoracic and Vascular Surgeons
Austin, Texas 78756
United StatesSite Not Available
Baylor College of Medicine - Houston
Houston, Texas 77030
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
Memorial Hermann
Houston, Texas 77030
United StatesSite Not Available
Heart Hospital at Baylor Plano
Plano, Texas 75093
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Sentara Medical Group
Norfolk, Virginia 23507
United StatesSite Not Available
University of Washington
Seattle, Washington 98195
United StatesSite Not Available
University of Wisconsin System
Madison, Wisconsin 53792
United StatesSite Not Available

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