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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936647
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jean Raymond, 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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Brain Aneurysm Unruptured Cerebral Aneurysm Ruptured Cerebral Aneurysm Cerebral Aneurysm Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling Device: WEB embolization device Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 18, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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




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 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

  2. 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

  3. 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

  4. Number of peri-operative complications [ Time Frame: ≥5 days ]
    Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)

  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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936647


Contacts
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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
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 0C1
Contact: Guylaine Gevry, BSc    514-890-8000 ext 27235    guylaine.gevry.chum@ssss.gouv.qc.ca   
Contact: Ruby Klink, PhD    514-890-8000 ext 26359    Ruby.Klink@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Sub-Investigator: Daniel Roy, MD         
Sub-Investigator: Alain Weill, MD         
Sub-Investigator: Daniela Iancu, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Jean Raymond, Principal Investigator, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03936647    
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

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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.: No
Keywords provided by Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM):
intracranial aneurysm
cerebral aneurysm
brain aneurysm
unruptured cerebral aneurysm
ruptured cerebral aneurysm
WEB embolization device
embolization
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Rupture
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries