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

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

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.

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