The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
- Conditions
- Intracranial AneurysmBrain AneurysmUnruptured Cerebral AneurysmRuptured Cerebral AneurysmCerebral Aneurysm
- Interventions
- Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coilingDevice: WEB embolization device
- Registration Number
- NCT03936647
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard conventional treatment (surgical or endovascular) surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling 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. WEB embolization device WEB embolization device Endovascular treatment with WEB, including standard management of thrombo-embolic risk
- Primary Outcome Measures
Name Time Method Number of patients with a modified Rankin Score (mRS) below or equal to 2 1 year from procedure mRS ≤2 from evaluation (questionnaire) at follow-up visits throughout study. Grading score is to be assessed as such: Grade 0 No symptoms at all. Grade 1 No significant disability despite symptoms; able to carry out all usual duties and activities Grade 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Grade 3 Moderate disability; requiring some help, but able to walk without assistance Grade 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Grade 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention Grade 6 Dead
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion 1 year from procedure complete or near complete occlusion of the aneurysm
- Secondary Outcome Measures
Name Time Method Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging 12 +/- 2 months Angiographic outcome (invasive or non-invasive imaging) results
Hospitalization time up to first post-procedure visit (around 1 month) Hospital stay (number of days)
Number of peri-operative complications ≥5 days Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
Incidence of discharge destination by type up to first post-procedure visit (around 1 month) Discharge disposition (home; other hospital; rehabilitation facility; death)
Number of index aneurysms necessitating or having received retreatment due to re-occurence Within 12 +/- 2 months Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage
Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2 within 1 week post-procedure, 1-3 months, and 12 months post-treatment mRS ≤2 from evaluation (questionnaire) at discharge and follow-up visits throughout study. Grading score is to be assessed as such: Grade 0 No symptoms at all. Grade 1 No significant disability despite symptoms; able to carry out all usual duties and activities Grade 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Grade 3 Moderate disability; requiring some help, but able to walk without assistance Grade 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Grade 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention Grade 6 Dead
Number of successful deployment of WEB device, coils or successful microsurgical, clipping, along with judgement of patency of parent arteries using imaging (depending on treatment received) within 1 hour from procedure Successful WEB deployment / aneurysm clipping / aneurysm coiling
Number of incidences of successful or unsuccesful patency of parent arteries using imaging within 1 hour from procedure Analysis of imaging to judge the patency of the parent arteries
Number of participants with stroke, neurological symptom or sign within 12 +/- 2 months Any new stroke, neurological symptom or sign
Trial Locations
- Locations (4)
University of Manitoba Hospital
🇨🇦Winnipeg, Manitoba, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
Hamilton Health Sciences - McMaster University
🇨🇦Hamilton, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada