Recruiting

GORE® TAG® CTAG

Sponsor:

W.L.Gore & Associates

Code:

NCT06658730

Conditions

Vascular Disease

Dissection

Dissection Aortic Aneurysm

Dissection of Aorta

Aneurysm Thoracic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular

Study Details

Brief summary:

An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.

Conditions

Vascular Disease

Dissection

Dissection Aortic Aneurysm

Dissection of Aorta

Aneurysm Thoracic

Study ID

NCT06658730

Start date

Jun 19, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2038

Anticipated

Primary completion date

Aug, 2038

Anticipated

Eligibility Criteria

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 an eligible registry device.\*
3. Patient is age ≥ 18 years at time of informed consent signature.

  • The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.

Exclusion Criteria:

1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
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 Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

  • The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Aneurysm/Other Isolated Lesion

Dissection

Interventions

Endovascular

TEVAR - thoracic endovascular aortic repair

Primary outcome measure

  • Deployment Technical Success [ Time Frame: Index Procedure ]
  • Lesion-related Mortality [ Time Frame: From time of index procedure through 10 years of follow-up ]
  • Lesion Rupture (treated area) [ Time Frame: Through 10 years post-procedure ]
  • Lesion Enlargement (treated area) [ Time Frame: Through 10 years post-procedure ]
  • Endoleaks [ Time Frame: Through 10 years post-procedure ]
  • Device Migration [ Time Frame: Through 10 years post-procedure ]
  • Loss of aortic / branch patency [ Time Frame: Through 10 years post-procedure ]
  • Stroke (All, Serious, Non-Serious) [ Time Frame: Through 10 years post-procedure ]
  • Paraplegia (within 30 days of index procedure) [ Time Frame: Within 30 days of index procedure ]
  • Paraparesis (within 30 days of index procedure) [ Time Frame: Within 30 days of index procedure ]
  • New onset renal failure (within 30 days of index procedure) [ Time Frame: Within 30 days of index procedure ]
  • Renal function deterioration [ Time Frame: Within 30 days of index procedure ]
  • Device integrity events (e.g., fracture, kinking, compression) [ Time Frame: Through 10 years post-procedure ]
  • Reintervention [ Time Frame: Through 10 years post-procedure ]

Central Contacts and Locations

Central contacts

Ashley Hoedt, MS

+1 928-864-3987ahoedt@wlgore.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Karen Site Coordinator

kas10@arizona.edu

Principal Investigator:

Wei Zhou, M.D.

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Stephanie Site Coordinator

stephanie.varela@med.usc.edu

Principal Investigator:

Sukgu Han, M.D.

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ayda Site Coordinator

Ayda.Aliyari@cshs.org

Principal Investigator:

Ali Azizzadeh, MD

Leland Stanford Junior University

Recruiting

Stanford, California, United States, 94305

Contacts

Suneetha Site Coordinator

satluri2@stanford.edu

Principal Investigator:

Kenneth Tran, M.D.

University of Florida - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Nancy Site Coordinator

nancy.hanson@surgery.ufl.edu

Principal Investigator:

Zain Shahid, M.D.

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Avennette Site Coordinator

apinto3@usf.edu

Eric Site Coordinator

eej11@usf.edu

Principal Investigator:

Charles Briggs, M.D.

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Yvonne Site Coordinator

yvdaniel@augusta.edu

Principal Investigator:

William Jordan, M.D.

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Terri Strickland

TStrickland@IUHealth.org

Principal Investigator:

Joel Corvera, MD

University of Maryland - Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Langford Site Coordinator

lwgreen@som.umaryland.edu

Principal Investigator:

Shahab Toursavadkohi, M.D.

The Hitchcock Foundation at Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Paulene Site Coordinator

pauline.sirrell@hitchcock.org

Principal Investigator:

Bjoern Suckow, M.D.

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Stephanie Site Coordinator

Stephanie.lynes@hmhn.org

Principal Investigator:

Michael Wilderman, M.D.

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Amber Site Coordinator

amber_fix@med.unc.edu

Chris Site Coordinator

cdburges@email.unc.edu

Principal Investigator:

Mark Farber, M.D.

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Hillary Site Coordinator

hillary.hood@duke.edu

Principal Investigator:

Chad Hughes, M.D.

University Hospitals - Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Camille Site Coordinator

Camille.Opperman@uhhospitals.org

Principal Investigator:

Jae-Sung Cho, M.D.

Baylor Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Sarah Site Coordinator

SarahAnn.Hooton@BSWHealth.org

Principal Investigator:

Dennis Gable, M.D.

Columbia Medical Center of Plano

Recruiting

Plano, Texas, United States, 75075

Contacts

Pauline Site Coordinator

pauline.matheri@hcahealthcare.com

Principal Investigator:

Edic Stephanian, M.D.

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84157

Contacts

Lexi Site Coordinator

lexi.maycock@imail.org

Principal Investigator:

Jane He, M.D.

Sentara Medical Group, Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23437

Contacts

Kara Site Coordinator

kvwiggin@sentara.com

Principal Investigator:

Animesh Rathore, M.D.

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Nicole Site Coordinator

byington@surgery.wisc.edu

Principal Investigator:

Courtney Morgan, M.D.

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Endovascular
  • CTAG
  • Post-market Registry
  • Observational
  • Multi-regional
  • Real world data
  • Together Registry
  • Gore Together Registry
  • Gore Together Aortic Registry
  • Conformable Thoracic Stent Graft
  • TGR 23-02TA
  • TGR23-02TA
  • GORE TAG

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 2026-08-19.