Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Last updated: April 30, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Cardiovascular Disease

Heart Disease

Treatment

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Clinical Study ID

NCT03728985
AAA 17-01
  • Ages > 19
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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)

  1. 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)

  1. Adequate access for TAMBE Device components (femoral, axillary, and / or brachialarteries as required)

  2. Age ≥ 19 years at the time of informed consent signature

  3. Male or infertile female

  4. Patient assessment favors an endovascular approach when compared to open surgicalrepair, as deemed by the treating physician

  5. Capable of complying with protocol requirements, including follow-up

  6. An Informed Consent Form signed by Subject or legal representative

  7. 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.

  8. 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:

  1. 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

  2. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the leftsubclavian artery.

  3. 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:

  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 indexprocedure)

  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 lastadministration) 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 oftreatment

  12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use aconduit 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 excludefrom blood flow

  14. Known sensitivities or allergies to the device materials

  15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or knownhypersensitivity to heparin

  16. Patient has body habitus or other medical condition which prevents adequatefluoroscopic and CT visualization of the aorta

  17. Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoingdialysis)

  18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated torequire surgical intervention within one year of study treatment

Study Design

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Phase:
Study Start date:
June 17, 2019
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Guy's and St. Thomas' NHS Foundation Trust

    London, SEH 7EH
    United Kingdom

    Site Not Available

  • St. Mary's Hospital, Imperial College Healthcare, NHS Trust

    London, W2 1NY
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California 94118
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • MedStar Health Research Institute - MedStar Washington Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida - Gainesville

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46226
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan - Cardiac Surgery

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Essentia Health

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Division of Vascular Surgery - Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Mount Sinai West

    New York, New York 10019
    United States

    Site Not Available

  • Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Sanger Heart & Vascular Institute

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPP Heart and Vascular Institute

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Tennessee -University Vascular Surgeons

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Cardiothoracic and Vascular Surgeons, PA (CTVS)

    Austin, Texas 78756
    United States

    Site Not Available

  • St. David's Healthcare

    Austin, Texas 78705
    United States

    Site Not Available

  • Baylor Heart & Vascular Hospital

    Dallas, Texas 75226
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75352
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • The Methodist Hospital - Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Sentara Medical Group

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Carilion Clinic Hospitals

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.