RecruitingNot ApplicableNCT03936647

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

250 participants

Start Date

Jul 18, 2019

Study Type

INTERVENTIONAL

Conditions

Intracranial Aneurysm

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician
aneurysm of maximum diameter of 4-11 mm
may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms
Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.
Ruptured aneurysms with WFNS ≤ 3

Exclusion Criteria4

Absolute contraindication to surgery, endovascular treatment or anesthesia
Patients unable to give informed consent
diameter of the aneurysm ≤ 4 mm but ≥ 11 mm
Ruptured aneurysms with WFNS 4 or 5

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Interventions

PROCEDUREsurgical 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.

DEVICEWEB embolization device

WEB embolization device