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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 19 to 20
  2. Lead sponsor: W.L.Gore & Associates to W.L.Gore & Associates
    • Study sites: 18 to 19
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 12 of 17 entries
  3. Study sites: 16 to 18v16
  4. Study sites: 15 to 16v15
  5. Study sites: 13 to 15v14
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 12 to 13v13
  2. Study sites: 10 to 12v12
  3. Study sites: 9 to 10v11
  4. Study sites: 7 to 9v10
  5. Study sites: 6 to 7v9
  6. Study sites: 5 to 6v8
  7. Study sites: 4 to 5v7
  8. Study sites: 3 to 4v6
  9. Study sites: 2 to 3v5
  1. Recruitment opened
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 2026 to Mar 2, 2026
    v4
  2. Study sites: 0 to 1v3
  3. Primary endpoints revised (11)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07166133
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortic Arch Dissection, Aortic Arch Aneurysm
Related terms Aneurysm, Aortic Arch, Dissection, Thoracic Aorta
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov