Registry to Evaluate Safety and Performance of p64, p48 MW, and p64 MW Flow Diverter Devices in Treating Intracranial Aneurysms in France

What this Trial Is About

This research aims to assess the safety and performance of the phenox GmbH Flow Diverter devicesspecifically the p64, p64 MW, and p48 MWin treating intracranial aneurysms located in both anterior and posterior brain circulation in France. The study includes patients who are treated according to the usual care practices at participating medical sites. Participants will receive treatment for their intracranial aneurysm using one of the phenox GmbH Flow Modulation Devices p64, p64 MW, or p48 MW. Approximately 200 subjects are expected to be enrolled, with about 160 receiving the p64 or p64 MW devices and 40 receiving the p48 MW device. Treatments follow standard care protocols at the study centers. During the study, participants will be monitored for complications during and after the procedure, device-related issues, aneurysm occlusion, retreatment rates, and overall morbidity and mortality over a 12-month period. Data collection includes assessments up to discharge and follow-up visits within the year. This observational registry tracks outcomes to understand device performance and patient safety throughout the study duration.

PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in France