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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling
  • WEB embolization device

Treatment groups

250 Participants
are divided into 2 treatment groups