Actively Recruiting
Long-term Characterization of GORE4 TAG4 Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Led by W.L.Gore & Associates · Updated on 2026-05-12
1500
Participants Needed
34
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are gathering long-term data on the performance of the GORE4 TAG4 Conformable Thoracic Stent Graft with ACTIVE CONTROL System in patients undergoing thoracic endovascular aortic repair (TEVAR) for lesions in the descending thoracic aorta. This observational registry aims to assess mid- and long-term outcomes over a 10-year follow-up period to confirm that TEVAR remains a suitable treatment option for selected patients. Participants treated with the GORE4 TAG4 stent graft as part of routine clinical practice will be followed to monitor device performance and patient outcomes. The study collects data prospectively from multiple regions without altering standard care. The registry will track patients treated for aneurysm, dissection, and other thoracic aortic lesions using this specific stent graft device. During the 10-year follow-up, researchers will evaluate many safety and effectiveness measures including technical success of device deployment, lesion-related mortality, lesion rupture or enlargement, endoleaks, device migration, and complications such as stroke, paraplegia, and renal issues. Additional outcomes include device integrity events and need for reintervention. Data on access-related complications and false lumen status will also be collected. Participants will undergo routine clinical evaluations and follow-up visits according to standard care practices throughout the study period.
CONDITIONS
Brief Title
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legally authorized representative provides written authorization and/or consent.
- Patient has been or is intended to be treated with the eligible registry device.
- Patient is age 18 years or older at the time of consent.
You will not qualify if you...
- Patient is unlikely to be available for standard follow-up visits per site's guidelines.
- Patient meets exclusion criteria required by local law.
- Patient is currently enrolled in or plans to enroll in another investigational drug or device study within 12 months of enrollment.
- Patient cannot be enrolled in another Together Registry module protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Index procedure day
Participants undergo thoracic endovascular aortic repair (TEVAR) with the GORE® TAG® Conformable Thoracic Stent Graft using the ACTIVE CONTROL System.
1 procedure visit (in-person)
Duration - Up to 10 years post-procedure
Participants are monitored for up to 10 years after the procedure to assess device performance, lesion status, and health outcomes.
Periodic follow-up visits as per routine clinical care
Trial Site Locations
Total: 34 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Leland Stanford Junior University
Stanford, California, United States, 94305
Actively Recruiting
5
MedStar Health, MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
6
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
7
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
8
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
9
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Maryland - Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
12
The Hitchcock Foundation at Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
13
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
14
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
15
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
16
University Hospitals - Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
18
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
19
Baylor Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
20
Columbia Medical Center of Plano
Plano, Texas, United States, 75075
Actively Recruiting
21
Intermountain Medical Center
Murray, Utah, United States, 84157
Actively Recruiting
22
Sentara Medical Group, Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23437
Actively Recruiting
23
University of Washington
Seattle, Washington, United States, 98195
Not Yet Recruiting
24
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
25
Rigshospitalet
Copenhagen, Denmark, DK-2100
Actively Recruiting
26
Centre Hospitalier Universitaire Strasbourg
Strasbourg, France, 67000
Actively Recruiting
27
Universitatsmedizin Frankfurt
Frankfurt, Germany
Actively Recruiting
28
Regensburg University Hospital
Regensburg, Germany, D-93053
Actively Recruiting
29
Regensburg University Hospital
Regensburg, Germany, D-93053
Actively Recruiting
30
Universitatsklinikum Ulm
Ulm, Germany, D-89081
Actively Recruiting
31
Laiko General Hospital of Athens
Athens, Greece, 11527
Actively Recruiting
32
IRCCS Policlinico di Milano
Milan, Italy
Actively Recruiting
33
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
34
Uppsala University
Uppsala, Sweden, SE-751 85
Actively Recruiting
Research Team
A
Ashley Hoedt, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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