An interventional study of surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling and WEB embolization device in Intracranial Aneurysm, Brain Aneurysm and Unruptured Cerebral Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 250 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling
Endovascular treatment with WEB, including standard management of thrombo-embolic risk
Device: WEB embolization device
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
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion
complete or near complete occlusion of the aneurysm
Time frame: 1 year from procedure
Number of patients with a modified Rankin Score (mRS) below or equal to 2
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
Time frame: 1 year from procedure
Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2
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
Time frame: within 1 week post-procedure, 1-3 months, and 12 months post-treatment
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)
Successful WEB deployment / aneurysm clipping / aneurysm coiling
Time frame: within 1 hour from procedure
Number of incidences of successful or unsuccesful patency of parent arteries using imaging
Analysis of imaging to judge the patency of the parent arteries
Time frame: within 1 hour from procedure
Number of peri-operative complications
Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
Time frame: ≥5 days
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
Angiographic outcome (invasive or non-invasive imaging) results
Time frame: 12 +/- 2 months
Hospitalization time
Hospital stay (number of days)
Time frame: up to first post-procedure visit (around 1 month)
Incidence of discharge destination by type
Discharge disposition (home; other hospital; rehabilitation facility; death)
Time frame: up to first post-procedure visit (around 1 month)
Number of participants with stroke, neurological symptom or sign
Any new stroke, neurological symptom or sign
Time frame: within 12 +/- 2 months
Number of index aneurysms necessitating or having received retreatment due to re-occurence
Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage
Time frame: Within 12 +/- 2 months
Plan to share: No
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Centre hospitalier de l'Université de Montréal (CHUM)