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

Recruiting now

Conditions studied: Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta, Aneurysm Thoracic, Aneurysm Dissecting, Transection Aorta, Intramural Hematoma

In brief

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.

Key facts

Study ID: NCT06658730
Run by: W.L.Gore & Associates
People needed: 1500
Starts: 2025-06-19
Expected to finish: 2038-08-01
Last updated by the study team: 2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
Patient has been or is intended to be treated with an eligible registry device.*
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.

You may not qualify if…

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.
Patient with exclusion criteria required by local law.
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).

Where it is running

Uppsala University — Uppsala, Sweden (enrolling)
University of Southern California — Los Angeles, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Leland Stanford Junior University — Stanford, California, United States (enrolling)
AORN S.Anna e S. Sebastiano — Caserta, Italy (enrolling)
IRCCS Policlinico di Milano — Milan, Italy (enrolling)
King Faisal Specialist Hospital and Research Center — Ryadh, Saudi Arabia (enrolling)
Hospital Universitari de Bellvitge — Barcelona, Spain (enrolling)
University of Arizona — Tucson, Arizona, United States (enrolling)
University of Florida - Gainesville — Gainesville, Florida, United States (enrolling)
University of South Florida — Tampa, Florida, United States (enrolling)
Augusta University — Augusta, Georgia, United States (enrolling)
Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
University of Maryland - Baltimore — Baltimore, Maryland, United States (enrolling)
The Hitchcock Foundation at Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
Duke University — Durham, North Carolina, United States (enrolling)
University Hospitals - Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
Baylor Research Institute — Dallas, Texas, United States (enrolling)
Columbia Medical Center of Plano — Plano, Texas, United States (enrolling)
Intermountain Medical Center — Murray, Utah, United States (enrolling)
Sentara Medical Group, Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
University of Wisconsin — Madison, Wisconsin, United States (enrolling)
Rigshospitalet — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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