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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Hamilton Health Sciences - McMaster University
RECRUITING
Hamilton
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montréal
University of Manitoba Hospital
RECRUITING
Winnipeg
Contact Information
Primary
daniela E Iancu, MD
daniela.iancu.med@ssss.gouv.qc.ca
514-890-8450
Backup
Guylaine Gevry, BSc
guylaine.gevry.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2019-07-18
Estimated Completion Date: 2026-01
Participants
Target number of participants: 250
Treatments
Active_comparator: Standard conventional treatment (surgical or endovascular)
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.
Experimental: WEB embolization device
Endovascular treatment with WEB, including standard management of thrombo-embolic risk
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov