A Prospective, Multicenter, Open-Label Randomized Trial Comparing Intracranial Visualized Stents for Treating Wide-Necked Brain Aneurysms

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new intracranial stent device for treating wide-necked intracranial aneurysms. This trial compares the new Microport NeuroTech Intracranial Visualized Stent with established devices called LVIS and LVIS Jr. The study aims to assess whether the new device is not inferior to current options in helping to close aneurysms. About 200 patients with intracranial aneurysms will participate in this prospective, randomized clinical trial across multiple centers. Participants will undergo stent-assisted coiling embolisation surgery using either the new Microport device or one of the control devices. The study is open-label and randomized, meaning patients are assigned to one of these treatment groups without masking. Follow-up will include imaging tests such as Digital Subtraction Angiography DSA and Magnetic Resonance Angiography MRA at surgery and at 6 and 12 months after surgery. The study carefully tracks the success of aneurysm occlusion and stent placement over time. Throughout the study, participants will be assessed before surgery, at device implantation, at hospital discharge, and at 1, 6, and 12 months post-surgery using the modified Rankin Scale mRS and imaging. Additional unplanned follow-ups may occur as needed. The main outcome measured is the rate of aneurysms with adequate occlusion at 6 months. Other outcomes include technical success of the stent, complete occlusion rates, in-stent narrowing, and the need for retreatment. Safety and efficacy will be monitored until the study ends in 2026.

Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE