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Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

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

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  1. 3 versions Re-verified since Feb 11, 2025, no change to tracked fieldsv29-v31
  2. Enrollment target: 246 to 250v28
  3. Re-verified, no change to tracked fieldsv27
  4. Results first posted: Nov 22, 2022v26 Show 9 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 315 to confirmed 246
    • Study sites: 40 to 35
    • Primary completion date changed from estimate of May 2022 to Apr 12, 2021
    • Study completion date: Dec 2026 to Dec 2027
    • Start date: Aug 2016 to Sep 6, 2016
    • Study description expanded, about 83 words
    • Study title shortened, about 4 words
  5. Primary completion date: Dec 2021 to May 2022
    • Site details revised at 6 of 40 sites
    v25
Show 23 earlier versionsHide 23 earlier versions
  1. Primary completion date: Aug 2021 to Dec 2021v24
  2. Primary completion date: Jul 2021 to Aug 2021
    • Study completion date: Nov 2024 to Dec 2026
    • Site details revised at 10 of 40 sites
    v23
  3. Re-verified, no change to tracked fieldsv22
  4. Primary completion date: Mar 2020 to Jul 2021
    • Study completion date: Nov 2023 to Nov 2024
    v21
  5. Site contacts updated at 1 of 40 sitesv20
  6. Primary completion date: Nov 2019 to Mar 2020v19
  7. Enrollment target: 285 to 315
    • Primary completion date: Jul 2019 to Nov 2019
    • Study completion date: Jul 2023 to Nov 2023
    v18
  8. Site details revised at 2 of 40 sitesv17
  9. Study sites: 38 to 40v16
  10. Study sites: 37 to 38v15
  11. Study sites: 35 to 37v14
  12. Site details revised at 1 of 35 sitesv13
  13. Study sites: 34 to 35v12
  14. Study sites: 33 to 34v11
  15. Study sites: 30 to 33v10
  16. Study sites: 29 to 30v9
  17. Study sites: 27 to 29v8
  18. Study sites: 21 to 27v7
  19. Study sites: 15 to 21v6
  20. Study sites: 12 to 15v5
  21. Study sites: 9 to 12
    • Eligibility criteria expanded, about 16 words
    v4
  22. Study sites: 4 to 9v3
  23. 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, requiring Zone 2 proximal implantation of the device.
Trial Details
NCT Number NCT02777593
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortic Aneurysm, Thoracic, Aorta; Lesion
Related terms Aortic Aneurysm, Thoracic
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov