NCT05543447 DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
| NCT ID | NCT05543447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Acandis GmbH |
| Condition | Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 158 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 158 participants in total. It began in 2022-12-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Previously treated aneurysms with flow diverter, stent or WEB device * Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient * Patient with a ruptured aneurysm in the acute phase of bleeding * Pre-treatment disability (mRS \> 2) * Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel * Contraindication against treatment with anti-platelet medication * 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
Contact & Investigator
Behme Daniel, Prof.
STUDY DIRECTOR
Universitätsklinikum Magdeburg
Frequently Asked Questions
Who can join the NCT05543447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05543447 currently recruiting?
Yes, NCT05543447 is actively recruiting participants. Contact the research team at info@acandis.com for enrollment information.
Where is the NCT05543447 trial being conducted?
This trial is being conducted at Augsburg, Germany, Berlin, Germany, Bremerhaven, Germany, Cologne, Germany and 11 additional locations.
Who is sponsoring the NCT05543447 clinical trial?
NCT05543447 is sponsored by Acandis GmbH. The principal investigator is Behme Daniel, Prof. at Universitätsklinikum Magdeburg. The trial plans to enroll 158 participants.