The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
RISE
1 other identifier
interventional
250
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 15, 2024
August 1, 2024
5.5 years
April 17, 2019
August 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
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
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
Number of incidences of successful or unsuccesful patency of parent arteries using imaging
within 1 hour from procedure
Number of peri-operative complications
≥5 days
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
12 +/- 2 months
- +4 more secondary outcomes
Study Arms (2)
Standard conventional treatment (surgical or endovascular)
ACTIVE COMPARATORTreatment 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.
WEB embolization device
EXPERIMENTALEndovascular treatment with WEB, including standard management of thrombo-embolic risk
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Manitoba Hospital
Winnipeg, Manitoba, R3E 3P5, Canada
Hamilton Health Sciences - McMaster University
Hamilton, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2019
First Posted
May 3, 2019
Study Start
July 18, 2019
Primary Completion
January 1, 2025
Study Completion
January 1, 2026
Last Updated
August 15, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share