DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Acandis GmbH
- Trial code
- NCT05543447
- Record updated
- 4 September 2025
- Original description
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.Read full original descriptionShow less
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device for Intracranial Aneurysms
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.
Inclusion: Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU; Age > 18 years; Signed Informed Consent Form; Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device; Effective use of antiplatelet medication confirmed by applicable testing method according to local standard.
Exclusion: Previously treated aneurysms with flow diverter, stent or WEB device; Patient with a ruptured aneurysm in the acute phase of bleeding; Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel; Contraindication against treatment with anti-platelet medication; Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient; Pre-treatment disability (mRS > 2); Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study; Participating in another study.