Study of the Contour Neurovascular System for Treating Wide-Necked Cerebral Aneurysms in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the Contour Neurovascular System CNS as a treatment for wide-necked, saccular, intracranial aneurysms. This trial aims to collect additional data to assess the safety and effectiveness of the CNS in treating these brain aneurysms. Participants include adults aged 18 to 75 with specific aneurysm characteristics requiring treatment, following guidelines for ruptured or unruptured aneurysms. Participants undergo treatment with the Contour Neurovascular System device during a procedure where its placement is attempted. After treatment, follow-up visits are scheduled at 1 month, 12 months, and 24 months to monitor progress. The study focuses on outcomes such as death or stroke within 30 days, aneurysm occlusion status after one year, and serious adverse events over two years. Throughout the study, participants report any adverse events to the research team and attend scheduled follow-up visits for evaluations. Researchers measure key outcomes including stroke incidence, neurological status, aneurysm closure, and device positioning. The total observation period covers up to two years post-treatment, with careful monitoring to evaluate the devices performance and safety.

Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)