Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
NCT ID: NCT03728985
Last Updated: 2025-10-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
102 participants
INTERVENTIONAL
2019-06-17
2026-09-30
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary Study Arm
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Secondary Study Arm
TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Interventions
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GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Endovascular Aortic Stent-Graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fusiform aneurysm diameter ≥ 5 cm
* Saccular aneurysm (no diameter requirement)
* Rapid aneurysm growth (≥ 5 mm in one year)
2. 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)
3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)
4. Age ≥ 19 years at the time of informed consent signature
5. Male or infertile female
6. Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician
7. Capable of complying with protocol requirements, including follow-up
8. An Informed Consent Form signed by Subject or legal representative
9. Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery.
10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:
* 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 be aneurysmal, heavily calcified, or heavily thrombosed
* Patent left subclavian artery
Secondary Study Arm Only:
11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm
12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery.
13. The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported
Exclusion Criteria
1. Prior open, aortic surgery of the ascending aorta or aortic arch
2. Ruptured or leaking aortic aneurysm
3. Aneurysmal dilatation due to chronic aortic dissection
4. Infected aorta
5. Mycotic aneurysm
6. Life expectancy \<2 years
7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
8. Systemic infection which may increase risk of endovascular graft infection
9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
10. Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening
11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
13. A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow
14. Known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
16. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
17. Renal Insufficiency (creatinine value \> 1.8 mg/dL, GFR \< 30, or patient undergoing dialysis)
18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment
19 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Farber, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAA 17-01
Identifier Type: -
Identifier Source: org_study_id
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