Randomized Study Comparing WEB Device and Standard Treatments for Intracranial Wide-Necked Bifurcation Aneurysms

What this Trial Is About

Researchers are investigating the best treatment for intracranial wide-necked bifurcation aneurysms WNBA, which are challenging to repair using endovascular methods. The study compares standard surgical and endovascular treatments with the WEB Woven EndoBridge device, a newer intra-saccular flow-diverting mesh that does not require anti-platelet therapy. The trial aims to determine which approach offers better outcomes for patients with aneurysms suitable for the WEB device. Participants will be randomly assigned to either standard conventional treatments, including surgical clipping, simple coiling, stenting, or intra-arterial flow diversion, or to receive the WEB embolization device. The choice of standard treatment will be predetermined by the treating physician before randomization. Both treatment options will be carefully managed and monitored. During the study, participants will undergo imaging to assess aneurysm occlusion and evaluations of neurological function using the modified Rankin Score at multiple time points up to one year after the procedure. Additional assessments include procedure success, parent artery patency, complications, aneurysm recurrence, hospitalization duration, and stroke occurrence. Safety and treatment effectiveness will be closely monitored throughout the study period, which extends up to one year from the procedure.

The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices