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Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

Study acronym: SSB 11-02
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv27
  2. Results first posted: Jun 25, 2025v26 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: estimated 150 to confirmed 79
    • Study description expanded, about 69 words
    • Study title shortened, about 4 words
  3. Re-verified, no change to tracked fieldsv25
  4. Primary endpoints: 1 to 2
    • Study sites: 34 to 39
    • Primary completion date: Feb 2024 to Mar 2024
    • Study completion date: Nov 2027 to Mar 2028
    v24
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 40 to 34
    • Primary completion date: Dec 2023 to Feb 2024
    v23
Show 21 earlier versionsHide 21 earlier versions
  1. Primary completion date: Jun 2022 to Dec 2023
    • Study completion date: Nov 2023 to Nov 2027
    • Study sites revised (40)
    v22
  2. Primary completion date: May 2023 to Jun 2022
    • Study completion date: Jul 2024 to Nov 2023
    • Site details revised at 10 of 40 sites
    v21
  3. Re-verified, no change to tracked fieldsv20
  4. Primary completion date: Jul 2020 to May 2023v19
  5. Re-verified, no change to tracked fieldsv18
  6. Site details revised at 2 of 40 sitesv17
  7. Study sites: 38 to 40v16
  8. Study sites: 37 to 38v15
  9. Study sites: 35 to 37v14
  10. Site details revised at 1 of 35 sitesv13
  11. Study sites: 34 to 35v12
  12. Study sites revised (34)v11
  13. Study sites: 30 to 34v10
  14. Study sites: 29 to 30v9
  15. Study sites: 27 to 29v8
  16. Study sites: 21 to 27v7
  17. Study sites: 15 to 21v6
  18. Study sites: 12 to 15v5
  19. Study sites: 9 to 12
    • Eligibility criteria expanded, about 25 words
    v4
  20. Study sites: 4 to 9v3
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 4
    • Start date: Jul 2016 to Aug 2016
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
Trial Details
NCT Number NCT02777528
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortic Aneurysm, Thoracic, Aorta, Lesion
Related terms Aortic Aneurysm, Thoracic
Enrollment 79 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov