Intracranial Aneurysm Clinical Trial
— RISEOfficial title:
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
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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