Actively Recruiting
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-08-15
250
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best treatment for intracranial wide-necked bifurcation aneurysms (WNBA), which are challenging to repair using endovascular methods. The study compares standard surgical and endovascular treatments with the WEB (Woven EndoBridge) device, a newer intra-saccular flow-diverting mesh that does not require anti-platelet therapy. The trial aims to determine which approach offers better outcomes for patients with aneurysms suitable for the WEB device. Participants will be randomly assigned to either standard conventional treatments, including surgical clipping, simple coiling, stenting, or intra-arterial flow diversion, or to receive the WEB embolization device. The choice of standard treatment will be predetermined by the treating physician before randomization. Both treatment options will be carefully managed and monitored. During the study, participants will undergo imaging to assess aneurysm occlusion and evaluations of neurological function using the modified Rankin Score at multiple time points up to one year after the procedure. Additional assessments include procedure success, parent artery patency, complications, aneurysm recurrence, hospitalization duration, and stroke occurrence. Safety and treatment effectiveness will be closely monitored throughout the study period, which extends up to one year from the procedure.
CONDITIONS
Brief Title
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has an intracranial aneurysm considered suitable for WEB treatment by the treating doctor
- Aneurysm maximum diameter is between 4 mm and 11 mm
- May include saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery
- Recurring or persistent aneurysm after previous treatment is allowed if morphology is appropriate
- Ruptured aneurysms with WFNS grade 3 or less
You will not qualify if you...
- Absolute contraindication to surgery, endovascular treatment, or anesthesia
- Unable to give informed consent
- Aneurysm diameter less than 4 mm or greater than 11 mm
- Ruptured aneurysms with WFNS grade 4 or 5
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and up to 5 days post-procedure
Participants receive either WEB embolization device treatment or standard conventional treatment such as surgical clipping, coiling, or stenting predetermined by their physician prior to randomization.
1 procedure visit and hospitalization up to 5 days
Duration - Up to 12 months
Participants are monitored through imaging and clinical assessments to evaluate aneurysm occlusion, neurological status, and potential complications.
Visits within 1 week post-procedure, 1 to 3 months, and around 12 months post-treatment
Trial Site Locations
Total: 4 locations
1
University of Alberta Hospital
Edmonton, Alberta, Canada
Actively Recruiting
2
University of Manitoba Hospital
Winnipeg, Manitoba, Canada, R3E 3P5
Actively Recruiting
3
Hamilton Health Sciences - McMaster University
Hamilton, Ontario, Canada
Actively Recruiting
4
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
Research Team
D
daniela E Iancu, MD
G
Guylaine Gevry, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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