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

Recruiting now

Conditions studied: Intracranial Aneurysm, Flow Diverter

In brief

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.

Key facts

Study ID

NCT05543447

Run by

Acandis GmbH

People needed

158

Starts

2022-12-15

Expected to finish

2026-12-01

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Universitätsklinikum Augsburg — Augsburg, Germany (enrolling)
• Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Klinikum Bremerhaven-Reinkenheide — Bremerhaven, Germany (enrolling)
• Universitätsklinikum Köln — Cologne, Germany (enrolling)
• Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (enrolling)
• Universitätsklinikum Düsseldorf — Düsseldorf, Germany (enrolling)
• Universitätsklinikum Essen — Essen, Germany (enrolling)
• Krankenhaus Nordwest Frankfurt — Frankfurt am Main, Germany (enrolling)
• Universitätsmedizin Halle — Halle, Germany (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Westpfalz-Klinikum Kaiserslautern — Kaiserslautern, Germany (enrolling)
• Universitätsklinikum Magdeburg — Magdeburg, Germany (enrolling)
• Mühlenkreiskliniken | Johannes Wesling Klinikum Minden — Minden, Germany (enrolling)
• Ludwig-Maximilians-Universität München — München, Germany (enrolling)
• Technische Universität München — München, Germany (enrolling)
• Klinikum Vest - Knappschaftskrankenhaus Recklinghausen — Recklinghausen, Germany (enrolling)
• Städtisches Klinikum Solingen — Solingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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