Monitoring the safety and outcomes of Acandis devices for treating brain aneurysms in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect clinical data on patients treated for intracranial aneurysms using Acandis devices. It will assess mortality, morbidity, and neurological outcomes 12 months post-treatment, while also evaluating any residual risks associated with the devices. The data collected will support the long-term safety and performance evaluation of these devices and assist in the renewal of their reimbursement in France.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
  Rouen, France Recruiting

Study contacts

• Study coordinator: Acandis GmbH
• Email: clinicalaffairs@acandis.com
• Phone: +49 7231 980 84 0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.