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Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v5
  2. Primary completion date: Oct 1, 2029 to Dec 1, 2029
    • Study completion date: Oct 1, 2034 to Dec 1, 2034
    v4
  3. Study sites: 3 to 10v3
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft \[ZTA\]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.
Trial Details
NCT Number NCT06094127
Lead Sponsor Cook Research Incorporated
Conditions
(from sponsor)		 Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
Related terms Aneurysm, Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov