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Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System

Study acronym: ARCUS
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Jul 2025 to Mar 2027
    • Enrollment target: 60 to 70
    • Study sites: 11 to 18
    • Study title revised
    v4
  2. Enrollment target: 30 to 60v3 Show 7 more changesShow less
    • Primary completion date: Jul 2024 to Jul 2025
    • Study sites: 6 to 11
    • Study completion date: Sep 2029 to Jul 2030
    • Eligibility criteria expanded, about 46 words
    • Study description shortened, about 210 words
    • Study title expanded, about 10 words
    • Study arms: 1 to 2
  3. Study sites: 3 to 6v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting. The main question\[s\] it aims to answer are: * Early mortality * Safety outcomes throughout the study * Device failure throughout the study * Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.
Trial Details
NCT Number NCT05636527
Lead Sponsor Endospan Ltd.
Conditions
(from sponsor)		 AAT9
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov