Thoracic Aortic Aneurysm Clinical Trials

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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Leland Stanford Junior University
RECRUITING
Stanford
Washington, D.c.
MedStar Health, MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Florida
University of Florida - Gainesville
RECRUITING
Gainesville
University of South Florida
RECRUITING
Tampa
Georgia
Augusta University
RECRUITING
Augusta
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Maryland
University of Maryland - Baltimore
RECRUITING
Baltimore
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University
RECRUITING
Durham
New Hampshire
The Hitchcock Foundation at Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Ohio
University Hospitals - Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Texas
Baylor Research Institute
RECRUITING
Dallas
Columbia Medical Center of Plano
RECRUITING
Plano
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
Sentara Medical Group, Sentara Norfolk General Hospital
RECRUITING
Norfolk
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
France
Centre Hospitalier Universitaire Strasbourg
RECRUITING
Strasbourg
Germany
Universitatsmedizin Frankfurt
RECRUITING
Frankfurt
Regensburg University Hospital
RECRUITING
Regensburg
Regensburg University Hospital
RECRUITING
Regensburg
Universitatsklinikum Ulm
RECRUITING
Ulm
Greece
Laiko General Hospital of Athens
RECRUITING
Athens
Italy
IRCCS Policlinico di Milano
RECRUITING
Milan
Spain
Hospital Universitari de Bellvitge
RECRUITING
Barcelona
Sweden
Uppsala University
RECRUITING
Uppsala
Contact Information
Primary
Ashley Hoedt, MS
ahoedt@wlgore.com
+1 928-864-3987
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2038-08
Participants
Target number of participants: 1500
Treatments
Aneurysm/Other Isolated Lesion
Dissection
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov