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

  • STATUS
    Recruiting
  • End date
    Jul 9, 2024
  • participants needed
    250
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 16 February 2022
ruptured aneurysm
intracranial aneurysm
embolization procedure
ruptured aneurysms
endovascular procedure

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.

Details
Condition Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm
Treatment surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling, WEB embolization device
Clinical Study IdentifierNCT03936647
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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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