Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

NCT02777528 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: SSB 11-02 Pivotal (Zone 0/1)
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 39

Brief Summary

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Conditions

Aortic Aneurysm, Thoracic; Aorta, Lesion

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1

  Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.

  1 month

• Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1

  Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure and absence of aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.

  12 months

Study Arms (2)

Zone 0/1 Aortic aneurysm

OTHER

Zone 0/1 Aortic aneurysm

Device: GORE® TAG® Thoracic Branch Endoprosthesis; Procedure: Revascularization Procedure

Zone 0/1 Non-aneurysm aortic lesions

OTHER

Includes dissection and other isolated lesion types

Device: GORE® TAG® Thoracic Branch Endoprosthesis; Procedure: Revascularization Procedure

Interventions

GORE® TAG® Thoracic Branch Endoprosthesis DEVICE

Endovascular repair with the TBE Device

Zone 0/1 Aortic aneurysm; Zone 0/1 Non-aneurysm aortic lesions

Revascularization Procedure PROCEDURE

Revascularization procedure of the great vessel

Zone 0/1 Aortic aneurysm; Zone 0/1 Non-aneurysm aortic lesions

Eligibility Criteria

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

You may qualify if:

• Presence of thoracic aortic pathology deemed to warrant surgical repair which requires 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 aortic landing zone.
• Native aortic valve (Zone 0/1 subjects only)
• Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)

You may not qualify if:

• Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring 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 for Ascending 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 developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
• Patient has a systemic infection and may be at increased risk of endovascular graft infection
• 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 study enrollment
• Known history of drug abuse within one year of treatment
• Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
• Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (39)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Leland Stanford Junior University

Stanford, California, 94305-5407, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MedStar Washington Hospital Center

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

Atlanta, Georgia, 30322, United States

Location

Northwesten University

Chicago, Illinois, 60611, United States

Location

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, 46290, United States

Location

University of Baltimore Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington Univeristy School of Medicine - St Louis

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Research Foundation SUNY Buffalo

Buffalo, New York, 14203, United States

Location

Carolinas HealthCare Systems

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

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Cardiovascular Surgery Clinic

Memphis, Tennessee, 38120, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Baylor College of Medicine - Houston

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

Heart Hospital at Baylor Plano

Plano, Texas, 75093, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin System

Madison, Wisconsin, 53792, United States

Location

Nagoya University Hospital

Aichi, Japan

Location

Morinomiya Hospital

Osaka, Japan

Location

Osaka University Hospital

Osaka, Japan

Location

Oita University Hospital

Ōita, Japan

Location

Jikei Medical University Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Meier Hsu
• Organization: WL Gore

mhsu@wlgore.com

928-864-3338

Study Officials

• Michael Dake, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Himanshu Patel, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 19, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Locations

JP (5); US (34)