GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

Part of paid clinical trials in Gainesville, Florida.

Sponsor
W.L.Gore & Associates
Study ID
NCT07166133
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Arch Aneurysm
  • Aortic Arch Dissection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GORE® TAG® Thoracic Branch Endoprosthesis — DEVICE
    Lesions in aortic arch in Zone 0 or Zone 1

Study Details

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Key Dates

Start date
Mar 2, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Mar 31, 2036

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device)

Primary Outcome Measure

Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure [ Time Frame: Index Endovascular Procedure Only ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Florida Health Heart & VascularGainesvilleFlorida32608
Martin Back, MD
[email protected]
352-273-5484
Martin Back, MD (PRINCIPAL_INVESTIGATOR)
Lakeland Regional Medical CenterLakelandFlorida33805
Mohammed Hassan, MD
[email protected]
863-413-5969
Mohammed Hassan, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
G. Chad Hughes IV, MD
[email protected]
919-668-0903
G. Chad Hughes IV, MD (PRINCIPAL_INVESTIGATOR)
The Methodist Hospital-HoustonHoustonTexas77030
Marvin Atkins, MD
[email protected]
713-441-5200
Marvin Atkins, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Medical CenterMurrayUtah84107
Jane He, MD
[email protected]
801-507-4700
Jane He, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Matthew Sweet, MD
[email protected]
206-598-8487
Matthew Sweet, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida Health Heart & Vascular· Gainesville, FLLakeland Regional Medical Center· Lakeland, FLDuke University Medical Center· Durham, NCThe Methodist Hospital-Houston· Houston, TXIntermountain Medical Center· Murray, UTUniversity of Washington Medical Center· Seattle, WA

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