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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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