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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03936647

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted April 17, 2020

Study Description

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.

  • Condition or Disease:Intracranial Aneurysm
    Brain Aneurysm
    Unruptured Cerebral Aneurysm
    Ruptured Cerebral Aneurysm
    Cerebral Aneurysm
  • Intervention/Treatment: Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling
    Device: WEB embolization device
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: July 2023
  • Estimated Study Completion Date: July 2024
Arms and interventions
Arm Intervention/treatment
Active Comparator: Standard conventional treatment (surgical or endovascular)
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
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.
Experimental: WEB embolization device
Endovascular treatment with WEB, including standard management of thrombo-embolic risk
Device: WEB embolization device
WEB embolization device
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants with imaging showing that index aneurysm has reached complete or near occlusion [ Time Frame: 1 year from procedure ]
    complete or near complete occlusion of the aneurysm
  • 2. Number of patients with a modified Rankin Score (mRS) below or equal to 2 [ Time Frame: 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
  • Secondary Outcome Measures: 1. Number of peri-operative complications [ Time Frame: ≥5 days ]
    Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
  • 2. Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2 [ Time Frame: 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
  • 3. 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) [ Time Frame: within 1 hour from procedure ]
    Successful WEB deployment / aneurysm clipping / aneurysm coiling
  • 4. Number of incidences of successful or unsuccesful patency of parent arteries using imaging [ Time Frame: within 1 hour from procedure ]
    Analysis of imaging to judge the patency of the parent arteries
  • 5. Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging [ Time Frame: 12 +/- 2 months ]
    Angiographic outcome (invasive or non-invasive imaging) results
  • 6. Hospitalization time [ Time Frame: up to first post-procedure visit (around 1 month) ]
    Hospital stay (number of days)
  • 7. Incidence of discharge destination by type [ Time Frame: up to first post-procedure visit (around 1 month) ]
    Discharge disposition (home; other hospital; rehabilitation facility; death)
  • 8. Number of participants with stroke, neurological symptom or sign [ Time Frame: within 12 +/- 2 months ]
    Any new stroke, neurological symptom or sign
  • 9. Number of index aneurysms necessitating or having received retreatment due to re-occurence [ Time Frame: Within 12 +/- 2 months ]
    Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Jean Raymond, MD 514-890-8000 ext 27235 jraymond.nri@gmail.com

Contact: Guylaine Gevry, BSc 514-890-8000 ext 27235 guylaine.gevry.chum@ssss.gouv.qc.ca

Locations

Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montréal

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

More Information
  • Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
  • ClinicalTrials.gov Identifier: NCT03936647 History of Changes
  • Other Study ID Numbers: 2020-8330
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: April 17, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM): unruptured cerebral aneurysm
    ruptured cerebral aneurysm
    WEB embolization device
    embolization
    intracranial aneurysm
    cerebral aneurysm
    brain aneurysm
  • Additional relevant MeSH terms: Intracranial Aneurysm
    Aneurysm
    Rupture