DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
Key facts
- Where
- Augsburg, Berlin, Bremerhaven, Cologne, Dresden, Düsseldorf, Essen, Frankfurt am Main, Halle, Hamburg, Kaiserslautern, Magdeburg, Minden, München, Recklinghausen, and Solingen, GermanySee the 17 sites
Where in Germany
- Universitätsklinikum AugsburgAugsburg, GermanyContact: Ansgar Berlis, Prof.Taking people
- Charité Universitätsmedizin BerlinBerlin, GermanyContact: George Bohner, Dr.Taking people
- Klinikum-Bremerhaven ReinkenheideBremerhaven, GermanyContact: Timo Phung, Dr.Taking people
- Universitätsklinikum KölnCologne, GermanyContact: Christoph Kabbasch, Prof.Taking people
- Universitätsklinikum Carl Gustav Carus DresdenDresden, GermanyContact: Johannes Gerber, Dr.Taking people
- Universitätsklinikum DüsseldorfDüsseldorf, GermanyContact: Bernd Turowski, Prof.Taking people
- Universitätsklinikum EssenEssen, GermanyContact: Cornelius Deuschl, Dr.Taking people
- Krankenhaus Nordwest FrankfurtFrankfurt am Main, GermanyContact: Ansgar Schütz, Dr.Taking people
- Universitätsmedizin HalleHalle, GermanyContact: Stefan Schob, PD Dr.Taking people
- Universitätsklinikum Hamburg-EppendorfHamburg, GermanyContact: Maxim Bester, PD Dr.Taking people
- Westpfalz-Klinikum - KaiserslauternKaiserslautern, GermanyContact: Andreas Simgen, Dr.Taking people
- Universitätsklinikum MagdeburgMagdeburg, GermanyContact: Behme Daniel, Prof.Taking people
- Mühlenkreiskliniken, Johannes Wesling Klinikum MindenMinden, GermanyContact: Christoph Mönninghoff, Prof.Taking people
- Ludwig-Maximilians-Universitat MunchenMünchen, GermanyContact: Thomas Liebig, Prof.Taking people
- Technische Universität MünchenMünchen, GermanyContact: Tobias Boeckh-Behrens, Dr.Taking people
- Klinikum Vest - Knappschaftskrankenhaus RecklinghausenRecklinghausen, GermanyContact: Christian Loehr, Dr.Taking people
- Städtisches Klinikum SolingenSolingen, GermanyContact: Hannes Nordmeyer, Dr.Taking people
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.