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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 310
    • Primary completion date: Jun 1, 2027 to Jun 25, 2027
    v4
  2. Primary completion date: Mar 1, 2028 to Jun 1, 2027
    • Study completion date: Mar 1, 2037 to Jun 1, 2036
    v3
  3. Phase: Phase 4 to Not applicable
    • Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2024 to Nov 25, 2024
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
Trial Details
NCT Number NCT06578741
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Related terms Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov