RecruitingNCT05543447
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device for Intracranial Aneurysms
Sponsor
Acandis GmbH
Enrollment
158 participants
Start Date
Dec 15, 2022
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria8
- 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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Interventions
DEVICEFlow Diverter Treatment with DERIVO 2 Heal Embolisation Device
Flow diversion therapy fpr intracranial aneurysm treatment.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT05543447
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