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The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2019-07-18
Completion Date
2026-01
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
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.
WEB embolization device
WEB embolization device
Locations (4)
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Manitoba Hospital
Winnipeg, Manitoba, Canada
Hamilton Health Sciences - McMaster University
Hamilton, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada