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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard conventional treatment (surgical or endovascular) | Active Comparator | 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 | Experimental | Endovascular treatment with WEB, including standard management of thrombo-embolic risk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with imaging showing that index aneurysm has reached complete or near occlusion | complete or near complete occlusion of the aneurysm | 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 | 1 year from procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| daniela E Iancu, MD | Contact | 514-890-8450 | daniela.iancu.med@ssss.gouv.qc.ca | |
| Guylaine Gevry, BSc | Contact | 514-890-8000 | 27235 | guylaine.gevry.chum@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Recruiting | Edmonton | Alberta | Canada |
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Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
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|
| WEB embolization device | Device | WEB embolization device |
|
| 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 | 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 | within 1 hour from procedure |
| Number of peri-operative complications | Peri-operative complications (such as ischemic strokes and intracranial hemorrhages) | ≥5 days |
| Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging | Angiographic outcome (invasive or non-invasive imaging) results | 12 +/- 2 months |
| Hospitalization time | Hospital stay (number of days) | up to first post-procedure visit (around 1 month) |
| Incidence of discharge destination by type | Discharge disposition (home; other hospital; rehabilitation facility; death) | 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 | 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 | Within 12 +/- 2 months |
| University of Manitoba Hospital | Recruiting | Winnipeg | Manitoba | R3E 3P5 | Canada |
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| Hamilton Health Sciences - McMaster University | Recruiting | Hamilton | Ontario | Canada |
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| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
|
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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