Early Safety and Feasibility Study of the LuSeed Aneurysm Embolization System for Treating Unruptured Brain Aneurysms in Adults

What this Trial Is About

Researchers are evaluating the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms IA. This prospective, single-arm, open-label, multi-center study will enroll up to 30 adults aged 18 to 80 who are approved for treatment under national or international guidelines. The trial aims to gather initial data on this device for non-emergency embolization of saccular IAs. Participants will receive treatment using the LuSeed Aneurysm Embolization System, a permanent implant designed for unruptured intracranial saccular aneurysms. The device is used in patients whose aneurysms meet specific size and location criteria, following guidelines for safe implantation. The study includes a single treatment attempt with this device and does not include a comparison group. Throughout the study, participants will be closely monitored with safety assessments at 30 days post-procedure and follow-ups extending to 12 months. Researchers will evaluate both safety and effectiveness outcomes at multiple time points including 6 and 12 months after treatment. Participants must be able to comply with all study visits and follow-up requirements, which include imaging and clinical evaluations to assess the devices performance and any adverse effects.

LUMENS-1 EU EFS CIP