DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcandis GmbH
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov