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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03936647
Other study ID # 2020-8330
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 18, 2019
Est. completion date January 2026

Study information

Verified date July 2023
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Jean Raymond, MD
Phone 514-890-8000
Email jraymond.nri@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
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.
Device:
WEB embolization device
WEB embolization device

Locations

Country Name City State
Canada Centre Hospitalier de l'Université de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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 within 1 week post-procedure, 1-3 months, and 12 months post-treatment
Secondary 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
Secondary 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
Secondary Number of peri-operative complications Peri-operative complications (such as ischemic strokes and intracranial hemorrhages) =5 days
Secondary 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
Secondary Hospitalization time Hospital stay (number of days) up to first post-procedure visit (around 1 month)
Secondary Incidence of discharge destination by type Discharge disposition (home; other hospital; rehabilitation facility; death) up to first post-procedure visit (around 1 month)
Secondary Number of participants with stroke, neurological symptom or sign Any new stroke, neurological symptom or sign within 12 +/- 2 months
Secondary 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
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