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Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Study acronym: COATING
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Dec 2025 to Dec 12, 2025
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 13 entries
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Recruiting to Active, Not Recruitingv8 Show 4 more changesShow less
    • Enrollment target: estimated 170 to confirmed 171
    • Study sites: 21 to 18
    • Primary completion date changed from estimate of Dec 2024 to Dec 4, 2024
    • Study completion date: Dec 2024 to Dec 2025
  3. Primary completion date: Jul 2023 to Dec 2024v7 Show 4 more changesShow less
    • Study sites: 17 to 21
    • Study completion date: Dec 2023 to Dec 2024
    • Secondary endpoints: 12 to 13
    • Eligibility criteria expanded, about 4 words
  4. Study sites: 13 to 17
    • Secondary endpoints: details revised at 9 of 12 entries
    v6
  5. Study sites: 10 to 13v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 6 to 10
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 12 entries
    v4
  2. Interventions: Endovascular treatment of unruptured aneurysms with p48/p64 MW HPC Flow Modulation Device (Device) to Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device (Device)
    • Eligibility criteria shortened, about 21 words
    • Site details revised at 2 of 6 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Jul 2021 to Sep 3, 2021
    • Secondary endpoints: 11 to 12
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
Trial Details
NCT Number NCT04870047
Lead Sponsor Phenox GmbH
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 171 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov