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Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE

Recruitingn/aAges 18 Years - anyAllAcandis GmbH
NCT06940934 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.

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📋 Eligibility rules (as published)
Inclusion Criteria: * The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms. * The subject is 18 years of age or older. * The subject is willing to comply with scheduled visits and examinations, per institution standard of care. Exclusion Criteria: * The subject has provided tacit opposition to data collection. * Any IFU warning will be considered for exclusion in the cohort.
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What it tests

  • Not listed
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Where

1 site
Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
Rouen, France
🤝 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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