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Flow Diverting Device

Endovascular Repair Techniques for Brain Aneurysm (RISE Trial)

N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aneurysm of maximum diameter of 4-11 mm
Ruptured aneurysms with WFNS ≤ 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year from procedure
Awards & highlights

RISE Trial Summary

This trial will compare surgical and endovascular repair of wide-necked bifurcation aneurysms to see which offers the best outcome for patients.

Who is the study for?
The RISE Trial is for patients with brain aneurysms suitable for a device called WEB. It's open to those with aneurysms 4-11 mm wide, including recurring ones if the shape fits treatment criteria. People can't join if they have contraindications to surgery or anesthesia, can't consent, or have very small (≤4mm) or large (≥11mm) aneurysms.Check my eligibility
What is being tested?
This trial tests different treatments for brain aneurysms: the WEB device that doesn’t need anti-platelet drugs, surgical clipping, coiling techniques, stenting and flow diversion methods. The best approach for wide-necked bifurcation aneurysms is being studied.See study design
What are the potential side effects?
Potential side effects may include complications from surgery like bleeding or infection, reactions to devices used such as irritation at implant site or allergic reaction to materials in the devices.

RISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My aneurysm is between 4 and 11 mm in size.
Select...
I had a ruptured aneurysm but am still able to perform daily activities.

RISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year from procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion
Number of patients with a modified Rankin Score (mRS) below or equal to 2
Secondary outcome measures
Hospitalization time
Incidence of discharge destination by type
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
+6 more

RISE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WEB embolization deviceExperimental Treatment1 Intervention
Endovascular treatment with WEB, including standard management of thrombo-embolic risk
Group II: Standard conventional treatment (surgical or endovascular)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,387 Total Patients Enrolled

Media Library

WEB embolization device (Flow Diverting Device) Clinical Trial Eligibility Overview. Trial Name: NCT03936647 — N/A
Brain Aneurysm Research Study Groups: WEB embolization device, Standard conventional treatment (surgical or endovascular)
Brain Aneurysm Clinical Trial 2023: WEB embolization device Highlights & Side Effects. Trial Name: NCT03936647 — N/A
WEB embolization device (Flow Diverting Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936647 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently receiving treatment through this clinical trial?

"Affirmative. According to the clinicaltrials.gov database, this medical exploration is recruiting participants as of now and was first published on July 18th 2019 with a last update being November 14th 2022. The trial requires 250 individuals from one single site for completion."

Answered by AI

Are there any vacancies available in this research project?

"Affirmative. The records on clinicaltrials.gov suggest that this trial is currently enrolling patients, as it was first published on July 18th 2019 and has been updated most recently on November 14th 2022. 250 individuals are desired for the study at one particular medical site."

Answered by AI

What tangible results are investigators hoping to observe from this trial?

"This clinical trial, which will be assessed over the course of a year from procedure commencement, has as its primary goal determining how many participants have imaging that indicates complete or near occlusion of their index aneurysm. Secondary outcomes involve assessing number of peri-operative complications (such as ischemic strokes and intracranial hemorrhages), amount of reoccurrences/ruptures/incomplete closures based on angiography results, and modified Rankin Scale scores below 2 at discharge. The latter score ranges 0 to 6 with grade 0 being no symptoms whatsoever while grade 6 indicating death."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Centre Hospitalier de l'Université de Montréal
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Jean Raymond 2019. "The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03936647.
~31 spots leftby Jan 2025
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