Post-Market Safety Study of Acandis Devices for Treating Intracranial Aneurysms in France

What this Trial Is About

Researchers are collecting clinical data to study patients who have been treated for intracranial aneurysms using commercial Acandis devices in France. The study focuses on assessing mortality, morbidity, and neurological outcomes 12 months after treatment. It also aims to evaluate any remaining risks related to the use of these devices and to ensure their long-term safety and performance on the French market. Additionally, the gathered data will support the renewal of reimbursement for these devices in France. The study involves patients treated with devices from the DERIVO family and the ACCLINO flex plus stent. These devices are used to treat intracranial aneurysms. As this is an observational study, no new treatments are administered instead, data is collected after the devices are placed as part of standard care. Participants will be monitored for at least 12 months following device implantation to track outcomes related to morbidity and mortality associated with the device or procedure. Follow-up includes scheduled visits and examinations according to usual medical practice. The main measurement is the morbi-mortality rate at approximately one year after treatment. The overall participation duration aligns with this 12-month post-treatment period.

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