Intracranial AneurysmRISENCT03936647
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
A study testing surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling and WEB embolization device in people with Intracranial Aneurysm and Brain Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm
- What is being tested?
- surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling and WEB embolization device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesCanada
- Study dates
- 18 Jul 2019to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
Tim E Darsaut, MD, tdarsaut@ualberta.ca
Tim E Darsaut, MD
- Recruiting
Hamilton Health Sciences - McMaster University
Hamilton, Ontario
Amanda Martyniuk, MSc, (905) 521-2100 ext. 44155, martynia@mcmaster.ca
Brian van Adel, MD
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Guylaine Gevry, BSc, 514-890-8000 ext. 27235, guylaine.gevry.chum@ssss.gouv.qc.ca
Ruby Klink, PhD, 514-890-8000 ext. 26359, Ruby.Klink@crchum.qc.ca
- Recruiting
University of Manitoba Hospital
Winnipeg, Manitoba, R3E 3P5
Susan Alcock, RN, MN, 204-789-3996, susan.alcock@umanitoba.ca
Jai Jay Shiva Shankar, MD
About this study
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.
- Conditions
- Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm
- Being tested
- surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling, WEB embolization device
- Keywords
- intracranial aneurysm, cerebral aneurysm, brain aneurysm, unruptured cerebral aneurysm, ruptured cerebral aneurysm, WEB embolization device, embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coilingProcedure or surgery
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.
WEB embolization deviceDevice
WEB embolization device
| Study group | Role | What they receive |
|---|---|---|
| Standard conventional treatment (surgical or endovascular) | Active comparator | 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. Receives: Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling |
| WEB embolization device | Experimental | Endovascular treatment with WEB, including standard management of thrombo-embolic risk Receives: Device: WEB embolization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion
complete or near complete occlusion of the aneurysm
Measured: 1 year from procedure
Number of patients with a modified Rankin Score (mRS) below or equal to 2
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
Measured: 1 year from procedure
Secondary outcomes (9)
Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2
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
Measured: 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)
Successful WEB deployment / aneurysm clipping / aneurysm coiling
Measured: within 1 hour from procedure
Number of incidences of successful or unsuccesful patency of parent arteries using imaging
Analysis of imaging to judge the patency of the parent arteries
Measured: within 1 hour from procedure
Number of peri-operative complications
Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
Measured: ≥5 days
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
Angiographic outcome (invasive or non-invasive imaging) results
Measured: 12 +/- 2 months
Hospitalization time
Hospital stay (number of days)
Measured: up to first post-procedure visit (around 1 month)
Incidence of discharge destination by type
Discharge disposition (home; other hospital; rehabilitation facility; death)
Measured: up to first post-procedure visit (around 1 month)
Number of participants with stroke, neurological symptom or sign
Any new stroke, neurological symptom or sign
Measured: within 12 +/- 2 months
Number of index aneurysms necessitating or having received retreatment due to re-occurence
Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage
Measured: Within 12 +/- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start18 Jul 2019
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936647
- Sponsor's protocol ID
- 2020-8330
- Acronym
- RISE
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2019
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
- ClinicalTrials.gov ID
- NCT03936647
- Acronym / sponsor ID
- RISE / 2020-8330
- Conditions
- Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm, Cerebral Aneurysm
- Keywords
- intracranial aneurysm, cerebral aneurysm, brain aneurysm, unruptured cerebral aneurysm, ruptured cerebral aneurysm, WEB embolization device, embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device
| Arm | Type | Receives |
|---|---|---|
| Standard conventional treatment (surgical or endovascular) | Active comparator | Procedure: surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coilingTreatment 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. |
| WEB embolization device | Experimental | Device: WEB embolization deviceEndovascular treatment with WEB, including standard management of thrombo-embolic risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coilingTreatment 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 or surgery | Standard conventional treatment (surgical or endovascular) |
| WEB embolization deviceWEB embolization device | Device | WEB embolization device |
Primary outcome
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
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
9 secondary outcomes
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
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
Number of incidences of successful or unsuccesful patency of parent arteries using imaging
Time frame: within 1 hour from procedure
Number of peri-operative complications
Time frame: ≥5 days
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging
Time frame: 12 +/- 2 months
Hospitalization time
Time frame: 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)
Number of participants with stroke, neurological symptom or sign
Time frame: within 12 +/- 2 months
Number of index aneurysms necessitating or having received retreatment due to re-occurence
Time frame: Within 12 +/- 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling and WEB embolization device in people with Intracranial Aneurysm and Brain Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact daniela E Iancu, MD (514-890-8450, daniela.iancu.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with imaging showing that index aneurysm has reached complete or near occlusion (time frame: 1 year from procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.