Recruiting

TBE DeviceGORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

Sponsor:

W.L.Gore & Associates

Code:

NCT07166133

Conditions

Aortic Arch Dissection

Aortic Arch Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GORE® TAG® Thoracic Branch Endoprosthesis

Study Details

Brief summary:

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Conditions

Aortic Arch Dissection

Aortic Arch Aneurysm

Study ID

NCT07166133

Start date

Mar 2, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2036

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
2. Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.
3. Patient is age ≥ 18 years at time of informed consent signature.

Exclusion Criteria:

1. Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.
2. Patient with exclusion criteria required by local law.
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Interventions

GORE® TAG® Thoracic Branch Endoprosthesis

Lesions in aortic arch in Zone 0 or Zone 1

Primary outcome measure

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure [ Time Frame: Index Endovascular Procedure Only ]
Device Technical Success (index procedure only) [ Time Frame: Index Endovascular Procedure Only ]
Lesion-related mortality [ Time Frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure ]
Disabling Stroke [ Time Frame: Within 30 days of surgical revascularization or within 30 days of index endovascular procedure ]
Permanent Paraplegia (within 30-days) [ Time Frame: Within 30 days of index endovascular procedure ]
Permanent Paraparesis (within 30-days) [ Time Frame: Within 30 days of index endovascular procedure ]
New onset renal failure (within 30-days) requiring on-going dialysis [ Time Frame: Within 30 days of index endovascular procedure ]
Lesion rupture (treated area) [ Time Frame: Minimum of 60 months and up to a maximum 120 months ]
Loss of aortic or branch patency [ Time Frame: Minimum of 60 months and up to a maximum of 120 months ]
Endoleaks [ Time Frame: Minimum of 60 months and up to a maximum of 120 months ]
Reintervention [ Time Frame: Minimum of 60 months and up to a maximum of 120 months ]

Central Contacts and Locations

Central contacts

DeAnne Hart

800-437-8181 tbe25-03@wlgore.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Hasan Aldailami, MD

480-246-3000 haldailami@honorhealth.com

Principal Investigator:

Hasan Aldailami, MD

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sukgu Han, MD

323-442-5849 sukgu.han@med.usc.edu

Principal Investigator:

Sukgu Han, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Akhilesh Jain, MD

860-522-4158 akhilesh.jain@hhchealth.org

Principal Investigator:

Akhilesh Jain, MD

MedStar Washington Hospital Center

Recruiting

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

Contacts

William Yoon, MD

202-877-5975 william.j.yoon@medstar.net

Principal Investigator:

William Yoon, MD

University of Florida Health Heart & Vascular

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Martin Back, MD

352-273-5484 martin.back@surgery.ufl.edu

Principal Investigator:

Martin Back, MD

Lakeland Regional Medical Center

Recruiting

Lakeland, Florida, United States, 33805

Contacts

Mohammed Hassan, MD

863-413-5969 mohammed.hassan@mylrh.org

Principal Investigator:

Mohammed Hassan, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Halim Yammine, MD

813-821-8034 hyammine@usf.edu

Principal Investigator:

Halim Yammine, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Mark Farber, MD

919-966-3391 mark_farber@med.unc.edu

Principal Investigator:

Mark Faber, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

G. Chad Hughes IV, MD

919-668-0903 gchad.hughes@duke.edu

Principal Investigator:

G. Chad Hughes IV, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Cecilia Chin, MD

617-835-9038 cecillia.chin@jefferson.edu

Principal Investigator:

Cecilia Chin, MD

The Methodist Hospital-Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Marvin Atkins, MD

713-441-5200 mdatkins@houstonmethodist.org

Principal Investigator:

Marvin Atkins, MD

Baylor Scott & White Research Institute

Recruiting

Plano, Texas, United States, 75093

Contacts

Justin Schaffer, MD

469-800-6200 justin.schaffer@bswhealth.org

Principal Investigator:

Justin Schaffer, MD

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Jane He, MD

801-507-4700 jane.he@imail2.org

Principal Investigator:

Jane He, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Matthew Sweet, MD

206-598-8487 mpsweet@uw.edu

Principal Investigator:

Matthew Sweet, MD

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Kyla Bennett, MD

608-265-4420 bennettk@surgery.wisc.edu

Principal Investigator:

Kyla Bennett, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Peter Rossi, MD

414-955-1800 prossi@mcw.edu

Principal Investigator:

Peter Rossi, MD

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

Zone 0
Zone 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-08-17.