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

Intracranial Aneurysm Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936647
• Other study ID #: 2020-8330
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm
• Ruptured Cerebral Aneurysm
• Unruptured Cerebral Aneurysm

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