Observational Study to Assess Safety and Effectiveness of Choydar Flow-Directed Mesh Stent for Treating Unruptured Intracranial Aneurysms

What this Trial Is About

Researchers are evaluating the safety and performance of the Choydar flow-directed mesh stent in treating unruptured intracranial aneurysms, which are bulging blood vessels in the brain that have not burst. This observational study is conducted in a real-world setting to observe how well the device works without additional interventions. The study is sponsored by Johnson & Johnson Medical Shanghai Ltd. and focuses on participants with specific aneurysm types and sizes in certain brain arteries. Participants will receive the Choydar flow-directed mesh stent according to its approved instructions. No other treatments are part of this study. The procedure targets wide-neck saccular or fusiform aneurysms in the internal carotid or vertebral arteries, with parent artery diameters between 2.0 and 6.0 millimeters. The study observes participants through a 12-month follow-up period after the procedure to assess success and safety. During the study, participants will be assessed at several points including the day of the procedure and at 12 months afterward. Researchers will monitor outcomes such as aneurysm occlusion rates, technical success of the procedure, re-treatment rates, functional neurological status, and any major ischemic, hemorrhagic events, or deaths. The study involves imaging and clinical evaluations to measure these outcomes and ensure participant safety throughout the follow-up period.

A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms