Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- W.L.Gore & Associates
- Study ID
- NCT06658730
- Status
- Recruiting
Conditions
- Aneurysm Dissecting
- Aneurysm Thoracic
- Dissection
- Dissection Aortic Aneurysm
- Dissection of Aorta
- Intramural Hematoma
- Transection Aorta
- Vascular Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Endovascular — DEVICETEVAR - thoracic endovascular aortic repair
Study Details
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 Dates
- Start date
- Jun 19, 2025
- Status verified
- May 2026
- Primary completion
- Aug 31, 2038
- Completion
- Aug 31, 2038
Study Design
- Enrollment
- 1,500 participants (estimated)
Arms
- Arm: Aneurysm/Other Isolated Lesion
- Arm: Dissection
Primary Outcome Measure
Deployment Technical Success [ Time Frame: Index Procedure ]
Central Contacts
- Ashley Hoedt, MS+1 928-864-3987
Locations (24)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | Karen Site Coordinator Wei Zhou, M.D. (PRINCIPAL_INVESTIGATOR) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Ayda Site Coordinator Ali Azizzadeh, MD (PRINCIPAL_INVESTIGATOR) |
| University of Southern California | Los Angeles | California | 90033 | Stephanie Site Coordinator Sukgu Han, M.D. (PRINCIPAL_INVESTIGATOR) |
| Leland Stanford Junior University | Stanford | California | 94305 | Suneetha Site Coordinator Kenneth Tran, M.D. (PRINCIPAL_INVESTIGATOR) |
| MedStar Health, MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Kassaye Site Coordinator William Yoon, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | Nancy Site Coordinator Zain Shahid, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of South Florida | Tampa | Florida | 33606 | Avennette Site Coordinator Eric Site Coordinator Charles Briggs, M.D. (PRINCIPAL_INVESTIGATOR) |
| Augusta University | Augusta | Georgia | 30912 | Yvonne Site Coordinator William Jordan, M.D. (PRINCIPAL_INVESTIGATOR) |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Terri Strickland Joel Corvera, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland - Baltimore | Baltimore | Maryland | 21201 | Langford Site Coordinator Shahab Toursavadkohi, M.D. (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Fernando Site Coordinator Marc Schermerhorn, M.D. (PRINCIPAL_INVESTIGATOR) |
| The Hitchcock Foundation at Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Paulene Site Coordinator Bjoern Suckow, M.D. (PRINCIPAL_INVESTIGATOR) |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Stephanie Site Coordinator Michael Wilderman, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Amber Site Coordinator Chris Site Coordinator Mark Farber, M.D. (PRINCIPAL_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27710 | Hillary Site Coordinator Chad Hughes, M.D. (PRINCIPAL_INVESTIGATOR) |
| University Hospitals - Cleveland Medical Center | Cleveland | Ohio | 44106 | Camille Site Coordinator Jae-Sung Cho, M.D. (PRINCIPAL_INVESTIGATOR) |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Ashley Site Coordinator Cecillia Chin, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Carolina Site Coordinator Grace Wang, M.D. (PRINCIPAL_INVESTIGATOR) |
| Baylor Research Institute | Dallas | Texas | 75246 | Sarah Site Coordinator Dennis Gable, M.D. (PRINCIPAL_INVESTIGATOR) |
| Columbia Medical Center of Plano | Plano | Texas | 75075 | Pauline Site Coordinator Edic Stephanian, M.D. (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84157 | Lexi Site Coordinator Jane He, M.D. (PRINCIPAL_INVESTIGATOR) |
| Sentara Medical Group, Sentara Norfolk General Hospital | Norfolk | Virginia | 23437 | Kara Site Coordinator Animesh Rathore, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Washington | Seattle | Washington | 98195 | Allison Site Coordinator Sara Zettervall, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin | Madison | Wisconsin | 53792 | Nicole Site Coordinator Courtney Morgan, M.D. (PRINCIPAL_INVESTIGATOR) |
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