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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Ruptured Cerebral Aneurysm; Brain Aneurysm; Intracranial Aneurysm; Unruptured Cerebral Aneurysm; Cerebral Aneurysm

Treatments: Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling; Device: WEB embolization device

Study type: Interventional

Funder types: Other

Identifiers

NCT03936647

2020-8330

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Standard conventional treatment (surgical or endovascular)

Active Comparator group

Description:

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.

Treatment:

Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

WEB embolization device

Experimental group

Description:

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Treatment:

Device: WEB embolization device