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

August 13, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta Hospital
        • Contact:
        • Principal Investigator:
          • Tim E Darsaut, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P5
        • Recruiting
        • University of Manitoba Hospital
        • Contact:
        • Principal Investigator:
          • Jai Jay Shiva Shankar, MD
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton Health Sciences - McMaster University
        • Contact:
        • Principal Investigator:
          • Brian van Adel, MD
    • Quebec
      • Montréal, Quebec, Canada, H2X 0C1
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Sub-Investigator:
          • Daniela Iancu, MD
        • Contact:
        • Principal Investigator:
          • Daniel Roy, MD
        • Sub-Investigator:
          • Alain Weill, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year from procedure
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
1 year from procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: within 1 hour from procedure
Successful WEB deployment / aneurysm clipping / aneurysm coiling
within 1 hour from procedure
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
within 1 hour from procedure
Number of peri-operative complications
Time Frame: ≥5 days
Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
≥5 days
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
12 +/- 2 months
Hospitalization time
Time Frame: up to first post-procedure visit (around 1 month)
Hospital stay (number of days)
up to first post-procedure visit (around 1 month)
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)
up to first post-procedure visit (around 1 month)
Number of participants with stroke, neurological symptom or sign
Time Frame: within 12 +/- 2 months
Any new stroke, neurological symptom or sign
within 12 +/- 2 months
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
Within 12 +/- 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2019

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-8330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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