Evaluating the DERIVO® 2heal® Embolisation Device for treating intracranial aneurysms
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device for Intracranial Aneurysms
This study is testing a new device to see if it safely and effectively treats brain aneurysms in patients over a three-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acandis GmbH Industry-sponsored |
| Locations | 17 sites (Augsburg and 16 other locations) |
| Trial ID | NCT05543447 on ClinicalTrials.gov |
What this trial studies
The DERIVO® 2heal® trial is a post-market clinical follow-up study assessing the safety and efficacy of the DERIVO® 2heal® Embolisation Device in treating intracranial aneurysms. Conducted in Germany across approximately 15 sites, this prospective, single-arm, open-label study will collect data on technical success, safety, and clinical outcomes over a period of 36 months for patient enrollment and an additional 12 months for follow-up. The study aims to identify any residual risks associated with the device and ensure its long-term performance in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years scheduled for treatment of a single intracranial aneurysm with the DERIVO® 2heal® Embolisation Device.
Not a fit: Patients with previously treated aneurysms or those with acute ruptured aneurysms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of treatments for patients with intracranial aneurysms.
How similar studies have performed: While this study builds on existing knowledge of flow diversion treatments, it specifically evaluates a new device, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Augsburg and 16 other locations
- Universitätsklinikum Augsburg — Augsburg, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Klinikum Bremerhaven-Reinkenheide — Bremerhaven, Germany (Recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, Germany (Recruiting)
- Krankenhaus Nordwest Frankfurt — Frankfurt am Main, Germany (Recruiting)
- Universitätsmedizin Halle — Halle, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Westpfalz-Klinikum Kaiserslautern — Kaiserslautern, Germany (Recruiting)
- Universitätsklinikum Magdeburg — Magdeburg, Germany (Recruiting)
- Mühlenkreiskliniken | Johannes Wesling Klinikum Minden — Minden, Germany (Recruiting)
- Ludwig-Maximilians-Universität München — München, Germany (Recruiting)
- Technische Universität München — München, Germany (Recruiting)
- Klinikum Vest - Knappschaftskrankenhaus Recklinghausen — Recklinghausen, Germany (Recruiting)
- Städtisches Klinikum Solingen — Solingen, Germany (Recruiting)
Study contacts
- Study coordinator: Acandis GmbH
- Email: info@acandis.com
- Phone: Tel: +49 7231 155 00 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.