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

NCT03728985 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: AAA 17-01
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 44

Brief 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)

Conditions

Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event

  Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events during Index Procedure: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety during 30 days of Index Procedure: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke

  From start of Index Procedure to 59 Days Post Procedure

• Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality

  Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons.

  12 Months

Secondary Outcomes (31)

• Percent of Subjects With Aneurysm-related Mortality

  30 days

• Percent of Subjects With Stented Segment Aortic Rupture

  30 days

• Percent of Subjects With Lesion Related Mortality

  30 days

• Percent of Subjects With Permanent Paraplegia

  30 days

• Percent of Subjects With Permanent Paraparesis

  30 days of index procedure

Study Arms (2)

Primary Study Arm

ACTIVE COMPARATOR

TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Secondary Study Arm

EXPERIMENTAL

TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Interventions

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis DEVICE

Endovascular Aortic Stent-Graft

Also known as: TAMBE

Primary Study Arm; Secondary Study Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least 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 brachial arteries 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 surgical repair, 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 patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery.
• Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:

You may not qualify if:

• 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 index procedure)
• 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 last administration) 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 of treatment
• Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit 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 exclude from blood flow
• Known sensitivities or allergies to the device materials

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (44)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94118, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MedStar Health Research Institute - MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32610, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46226, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan - Cardiac Surgery

Ann Arbor, Michigan, 48109, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Division of Vascular Surgery - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPP Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee -University Vascular Surgeons

Knoxville, Tennessee, 37920, United States

Location

St. David's Healthcare

Austin, Texas, 78705, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Texas Southwestern

Dallas, Texas, 75352, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The Methodist Hospital - Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Carilion Clinic Hospitals

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, 53215, United States

Location

Guy's and St. Thomas' NHS Foundation Trust

London, SEH 7EH, United Kingdom

Location

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

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Rizwan Afzal
• Organization: W.L. Gore and Associates

rafzal@wlgore.com

1-623-234-5408

Study Officials

• Mark Farber, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: This study contains two single arm substudies. A primary study arm and a secondary study arm.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: November 2, 2018
• Study Start: June 17, 2019
• Primary Completion: January 4, 2023
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 27, 2026
• Results First Posted: August 5, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (42); GB (2)