The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

Study Overview
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Brief Summary
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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.

Official Title
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The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

Conditions
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Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm

Intervention / Treatment
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* Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling
* Device: WEB embolization device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard conventional treatment (surgical or endovascular)<br>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<br>* 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.<br>|
| Experimental: WEB embolization device<br>Endovascular treatment with WEB, including standard management of thrombo-embolic risk | Device: WEB embolization device<br>* WEB embolization device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, cerebral aneurysm, brain aneurysm, unruptured cerebral aneurysm, ruptured cerebral aneurysm, WEB embolization device, embolization