Phase
Condition
Aneurysm
Cardiovascular Disease
Heart Disease
Treatment
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aortic aneurysm involving the visceral vessels requiring treatment defined as atleast one of the following:
Fusiform aneurysm diameter ≥ 5 cm
Saccular aneurysm (no diameter requirement)
Rapid aneurysm growth (≥ 5 mm in one year)
- Aortic aneurysm that involves the abdominal aorta, with:
Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or
No normal aorta between the upper extent of aneurysm and renal artery(s)
Adequate access for TAMBE Device components (femoral, axillary, and / or brachialarteries as required)
Age ≥ 19 years at the time of informed consent signature
Male or infertile female
Patient assessment favors an endovascular approach when compared to open surgicalrepair, as deemed by the treating physician
Capable of complying with protocol requirements, including follow-up
An Informed Consent Form signed by Subject or legal representative
Sufficient distal landing zones in both iliac arteries, with at least one patentinternal iliac artery and without planned placement of a branched iliac device, orplanned coverage/occlusion/embolization of any patent internal iliac artery.
Appropriate aortic anatomy to receive the TAMBE Device defined as all of thefollowing:
For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm
Proximal seal zone ≥ 20 mm in length
Aortic neck angle ≤ 60°
Distal landing zone (iliac arteries) 8-25 mm
Distal seal zone in iliac arteries of at least 10 mm in length
Renal artery landing zone diameters between 4-10 mm
Celiac and superior mesenteric artery landing zone diameters between 5-12 mm
≥ 15 mm landing zone in each branch vessel
Landing zones in the proximal and distal aorta and all branch vessels cannot beaneurysmal, heavily calcified, or heavily thrombosed
Patent left subclavian artery Secondary Study Arm Only:
If aneurysm extends greater than 65 mm above celiac artery, proximal extension witha CTAG Device is required. The aortic landing zone diameter treatment range with theCTAG Device is 19.5-32 mm
The most proximal aspect of the aneurysm is at least 2.0 cm distal to the leftsubclavian artery.
The most proximal aortic device seal zone will be within native aorta or apreviously-deployed TAG or CTAG Device • Placement inside a Dacron graft or anotherdevice manufacturer's stent graft will not be supported
Exclusion
Exclusion Criteria:
The patient is / has:
Prior open, aortic surgery of the ascending aorta or aortic arch
Ruptured or leaking aortic aneurysm
Aneurysmal dilatation due to chronic aortic dissection
Infected aorta
Mycotic aneurysm
Life expectancy <2 years
Myocardial infarction or stroke within 1 year of treatment (staged or indexprocedure)
Systemic infection which may increase risk of endovascular graft infection
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in an investigational drug study (within 30 days of lastadministration) or investigational medical device study (within 1 year of implant)from the time of study screening
History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year oftreatment
Tortuous or stenotic iliac and / or femoral arteries and the inability to use aconduit for vascular access
A branch vessel(s) that is dissected or has significant calcification, tortuosity,thrombus formation that would interfere with device delivery or ability to excludefrom blood flow
Known sensitivities or allergies to the device materials
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or knownhypersensitivity to heparin
Patient has body habitus or other medical condition which prevents adequatefluoroscopic and CT visualization of the aorta
Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoingdialysis)
Known concomitant aneurysm of the ascending aorta or aortic arch anticipated torequire surgical intervention within one year of study treatment
Study Design
Connect with a study center
Guy's and St. Thomas' NHS Foundation Trust
London, SEH 7EH
United KingdomSite Not Available
St. Mary's Hospital, Imperial College Healthcare, NHS Trust
London, W2 1NY
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Keck Medical Center of USC
Los Angeles, California 90033
United StatesSite Not Available
Kaiser Permanente San Francisco Medical Center
San Francisco, California 94118
United StatesSite Not Available
Stanford University
Stanford, California 94305
United StatesSite Not Available
MedStar Health Research Institute - MedStar Washington Hospital
Washington, District of Columbia 20010
United StatesSite Not Available
University of Florida - Gainesville
Gainesville, Florida 32610
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46226
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Michigan - Cardiac Surgery
Ann Arbor, Michigan 48109
United StatesSite Not Available
Essentia Health
Duluth, Minnesota 55805
United StatesSite Not Available
Division of Vascular Surgery - Minneapolis Heart Institute
Minneapolis, Minnesota 55407
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
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Mount Sinai West
New York, New York 10019
United StatesSite Not Available
Weill Cornell Medical Center
New York, New York 10065
United StatesSite Not Available
University of Rochester
Rochester, New York 14627
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Sanger Heart & Vascular Institute
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
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPP Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
University of Tennessee -University Vascular Surgeons
Knoxville, Tennessee 37920
United StatesSite Not Available
Cardiothoracic and Vascular Surgeons, PA (CTVS)
Austin, Texas 78756
United StatesSite Not Available
St. David's Healthcare
Austin, Texas 78705
United StatesSite Not Available
Baylor Heart & Vascular Hospital
Dallas, Texas 75226
United StatesSite Not Available
University of Texas Southwestern
Dallas, Texas 75352
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
The Methodist Hospital - Houston
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center
Houston, Texas 77030
United StatesSite Not Available
Sentara Medical Group
Norfolk, Virginia 23507
United StatesSite Not Available
Carilion Clinic Hospitals
Roanoke, Virginia 24014
United StatesSite Not Available
University of Washington
Seattle, Washington 98195
United StatesSite Not Available
University of Wisconsin - Madison
Madison, Wisconsin 53792
United StatesSite Not Available
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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