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DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

Study acronym: REheal
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 4, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Study sites: 2 to 17
    • Primary completion date: Oct 2025 to Dec 2025
    • Study completion date: Oct 2026 to Dec 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 2022 to Dec 15, 2022
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.
Trial Details
NCT Number NCT05543447
Lead Sponsor Acandis GmbH
Conditions
(from sponsor)		 Intracranial Aneurysm, Flow Diverter
Related terms Aneurysm, Intracranial Aneurysm
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov