NCT03936647

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.

Conditions

• Intracranial Aneurysm
• Brain Aneurysm
• Unruptured Cerebral Aneurysm
• Ruptured Cerebral Aneurysm
• Cerebral Aneurysm

Interventions

Type	Name	Description
PROCEDURE	surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling	Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.
DEVICE	WEB embolization device	WEB embolization device

Timeline

• Start date: 2019-07-18
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2019-05-03
• Last updated: 2024-08-15

Locations

4 sites across 1 country: Canada