Brain Aneurysm, Cerebral Aneurysm, Intracranial Aneurysm, Ruptured Cerebral Aneurysm, Unruptured Cerebral Aneurysm
Conditions
Keywords
intracranial aneurysm, cerebral aneurysm, brain aneurysm, unruptured cerebral aneurysm, ruptured cerebral aneurysm, WEB embolization device, embolization
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.
Interventions
PROCEDUREsurgical 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.
DEVICEWEB embolization device
WEB embolization device
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 peri-operative complications | ≥5 days | Peri-operative complications (such as ischemic strokes and intracranial hemorrhages) |
| 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 |
| 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 |
| 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 participants with stroke, neurological symptom or sign | within 12 +/- 2 months | Any new stroke, neurological symptom or sign |
| 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 |
| Hospitalization time | up to first post-procedure visit (around 1 month) | Hospital stay (number of days) |
| 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 |
Countries
Canada
Contacts
Primary Contactdaniela E Iancu, MD
Backup ContactGuylaine Gevry, BSc
Outcome results
None listed