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Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Sep 1, 2026 to Mar 1, 2029
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2026 to Mar 1, 2029
    • Site details revised at 4 of 4 sites
    v10
  2. Eligibility criteria expanded, about 2 wordsv9
  3. Study sites: 5 to 4
    • Interventions: Accero® Stent (Device) to Accero® (heal) Stent (Device)
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 1 word
    v8
  4. Primary completion date: Sep 1, 2024 to Sep 1, 2026
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v7
  5. Re-verified, no change to tracked fieldsv6
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  1. Study sites: 2 to 5v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 200 to 130
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 2019 to Jul 23, 2019
    v3
  4. Secondary endpoints: details revised at 4 of 4 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.
Trial Details
NCT Number NCT03957382
Lead Sponsor Acandis GmbH
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov