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Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA

Study acronym: ARTIZEN
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 23 → 26 locations
  2. Study sites: 22 to 23
  3. Study sites: 21 to 22
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 3 of 10 entries
  4. Study sites: 19 to 21v9
  5. Trial sites expanded: 16 → 19 locationsv8
  6. Trial sites expanded: 10 → 16 locationsv7
  7. Site contacts updated at 1 of 10 sitesv6
  8. Study sites: 7 to 10v5
  9. Study sites: 4 to 7v4
  10. Study sites: 1 to 4v3
  11. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 2028 to Apr 2028
    • Study completion date: Jun 2032 to Jul 2032
    • Start date changed from estimate of Sep 2025 to Nov 4, 2025
    • Site details revised
  12. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.
Trial Details
NCT Number NCT07089576
Lead Sponsor Artivion Inc.
Collaborators: Bright Research Partners
Conditions
(from sponsor)		 Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection, Acute Aortic Dissection
Related terms Aneurysm, Aortic Arch, Dissection, Thoracic Aorta
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov