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 — DEVICE
    TEVAR - 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

Locations (24)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Karen Site Coordinator
Wei Zhou, M.D. (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Ayda Site Coordinator
Ali Azizzadeh, MD (PRINCIPAL_INVESTIGATOR)
University of Southern CaliforniaLos AngelesCalifornia90033
Stephanie Site Coordinator
Sukgu Han, M.D. (PRINCIPAL_INVESTIGATOR)
Leland Stanford Junior UniversityStanfordCalifornia94305
Suneetha Site Coordinator
Kenneth Tran, M.D. (PRINCIPAL_INVESTIGATOR)
MedStar Health, MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Kassaye Site Coordinator
William Yoon, M.D. (PRINCIPAL_INVESTIGATOR)
University of Florida - GainesvilleGainesvilleFlorida32610
Nancy Site Coordinator
Zain Shahid, M.D. (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Avennette Site Coordinator
Eric Site Coordinator
Charles Briggs, M.D. (PRINCIPAL_INVESTIGATOR)
Augusta UniversityAugustaGeorgia30912
Yvonne Site Coordinator
William Jordan, M.D. (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianapolisIndiana46202
Terri Strickland
Joel Corvera, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland - BaltimoreBaltimoreMaryland21201
Langford Site Coordinator
Shahab Toursavadkohi, M.D. (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Fernando Site Coordinator
Marc Schermerhorn, M.D. (PRINCIPAL_INVESTIGATOR)
The Hitchcock Foundation at Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756
Paulene Site Coordinator
Bjoern Suckow, M.D. (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Stephanie Site Coordinator
Michael Wilderman, M.D. (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Amber Site Coordinator
Chris Site Coordinator
Mark Farber, M.D. (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Hillary Site Coordinator
Chad Hughes, M.D. (PRINCIPAL_INVESTIGATOR)
University Hospitals - Cleveland Medical CenterClevelandOhio44106
Camille Site Coordinator
Jae-Sung Cho, M.D. (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Ashley Site Coordinator
Cecillia Chin, M.D. (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Carolina Site Coordinator
Grace Wang, M.D. (PRINCIPAL_INVESTIGATOR)
Baylor Research InstituteDallasTexas75246
Sarah Site Coordinator
Dennis Gable, M.D. (PRINCIPAL_INVESTIGATOR)
Columbia Medical Center of PlanoPlanoTexas75075
Pauline Site Coordinator
Edic Stephanian, M.D. (PRINCIPAL_INVESTIGATOR)
Intermountain Medical CenterMurrayUtah84157
Lexi Site Coordinator
Jane He, M.D. (PRINCIPAL_INVESTIGATOR)
Sentara Medical Group, Sentara Norfolk General HospitalNorfolkVirginia23437
Kara Site Coordinator
Animesh Rathore, M.D. (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Allison Site Coordinator
Sara Zettervall, M.D. (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53792
Nicole Site Coordinator
Courtney Morgan, M.D. (PRINCIPAL_INVESTIGATOR)

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