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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Study acronym: TAMBE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Jun 3, 2026, no change to tracked fieldsv25-v26
  2. Study completion date: Sep 2026 to Jan 2030v24
  3. Re-verified, no change to tracked fieldsv23
  4. Study sites revised (44)v22
  5. 2 versions Re-verified since Nov 22, 2024, no change to tracked fieldsv20-v21
Show 18 earlier versionsHide 18 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 44 of 44 sites
    v19
  2. Results first posted: Aug 5, 2024v18 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 122 to 102
    • Primary completion date changed from estimate of Jun 2026 to Jan 4, 2023
    • Secondary endpoints revised (31)
    • Site contacts updated at 1 of 44 sites
  3. Re-verified, no change to tracked fieldsv17
  4. Site contacts updated at 1 of 44 sitesv16
  5. 2 versions Re-verified since Sep 29, 2023, no change to tracked fieldsv14-v15
  6. Site contacts updated at 1 of 44 sitesv13
  7. Site contacts updated at 1 of 44 sitesv12
  8. 3 versions Re-verified since Nov 23, 2021, no change to tracked fieldsv9-v11
  9. Site contacts updated at 1 of 44 sitesv8
  10. Site contacts updated at 2 of 44 sitesv7
  11. Study sites: 1 to 44v6
  12. Eligibility criteria expanded, about 12 wordsv5
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2019 to Jun 17, 2019
    • Site details revised
    v4
  14. Lead sponsor: [Redacted] to W.L.Gore & Associatesv3 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Jun 2026
    • Study completion date: Sep 2026
    • Start date: Jun 2019
    • Study title expanded, about 4 words
  15. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Trial Details
NCT Number NCT03728985
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Thoracoabdominal Aortic Aneurysm
Related terms Aortic Aneurysm, Thoracoabdominal
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov