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
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with an intracranial aneurysm for which WEB is considered an appropriate treatment by the participating clinician
- Aneurysm maximum diameter between 4 and 11 mm
- May include saccular bifurcation aneurysms of middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery
- Recurring or persistent aneurysm after previous treatment if morphology is suitable
- Ruptured aneurysms with WFNS score of 3 or less
You will not qualify if you...
- Absolute contraindication to surgery, endovascular treatment, or anesthesia
- Patients unable to give informed consent
- Aneurysm diameter less than 4 mm or greater than 11 mm
- Ruptured aneurysms with WFNS score of 4 or 5
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
G
Guylaine Gevry, BSc
CONTACT
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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