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NCT06658730Recruiting

Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

W.L.Gore & Associates

Start Date

6/19/2025

Completion Date

8/1/2038

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DEVICE

Endovascular

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Conditions

Vascular DiseaseDissectionDissection Aortic AneurysmDissection of AortaAneurysm ThoracicAneurysm DissectingTransection AortaIntramural Hematoma

Locations

University of Arizona

Tucson, Arizona 85724

United States

University of Southern California

Los Angeles, California 90033

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Leland Stanford Junior University

Stanford, California 94305

United States

MedStar Health, MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

University of Florida - Gainesville

Gainesville, Florida 32610

United States

University of South Florida

Tampa, Florida 33606

United States

Augusta University

Augusta, Georgia 30912

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

University of Maryland - Baltimore

Baltimore, Maryland 21201

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

The Hitchcock Foundation at Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University

Durham, North Carolina 27710

United States

University Hospitals - Cleveland Medical Center

Cleveland, Ohio 44106

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Baylor Research Institute

Dallas, Texas 75246

United States

Columbia Medical Center of Plano

Plano, Texas 75075

United States

Intermountain Medical Center

Murray, Utah 84157

United States

Sentara Medical Group, Sentara Norfolk General Hospital

Norfolk, Virginia 23437

United States

University of Washington

Seattle, Washington 98195

United States

University of Wisconsin

Madison, Wisconsin 53792

United States

Rigshospitalet

Copenhagen, DK-2100

Denmark

Centre Hospitalier Universitaire Strasbourg

Strasbourg, 67000

France

Universitatsmedizin Frankfurt

Frankfurt,

Germany

Regensburg University Hospital

Regensburg, D-93053

Germany

Regensburg University Hospital

Regensburg, D-93053

Germany

Universitatsklinikum Ulm

Ulm, D-89081

Germany

Laiko General Hospital of Athens

Athens, 11527

Greece

AORN S.Anna e S. Sebastiano

Caserta,

Italy

IRCCS Policlinico di Milano

Milan,

Italy

King Faisal Specialist Hospital and Research Center

Ryadh,

Saudi Arabia

Hospital Universitari de Bellvitge

Barcelona, 08907

Spain

Uppsala University

Uppsala, SE-751 85

Sweden