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

Recruitingn/aAges 18 Years - anyAllAcandis GmbH
NCT05543447 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device
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Where

17 sites
Universitätsklinikum Augsburg
Augsburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Klinikum Bremerhaven-Reinkenheide
Bremerhaven, Germany
Universitätsklinikum Köln
Cologne, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, Germany

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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