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

Not Applicable

Recruiting

• Conditions: Intracranial Aneurysm; Brain Aneurysm; Unruptured Cerebral Aneurysm; Ruptured Cerebral Aneurysm; Cerebral Aneurysm

• Registration Number: NCT03936647
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Study Start: 2019-07-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
Hospitalization time	up to first post-procedure visit (around 1 month)	Hospital stay (number of days)
Number of peri-operative complications	≥5 days	Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
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
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
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
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 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
Number of participants with stroke, neurological symptom or sign	within 12 +/- 2 months	Any new stroke, neurological symptom or sign

Trial Locations

Locations (4)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Manitoba Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Hamilton Health Sciences - McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada