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出境医 / 临床实验 / The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices (RISE)
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices (RISE)
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
| 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.
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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.
|
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Experimental: WEB embolization device
Endovascular treatment with WEB, including standard management of thrombo-embolic risk
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Device: WEB embolization device
WEB embolization device
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Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
- 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
- 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
- Number of peri-operative complications [ Time Frame: ≥5 days ]Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)
- 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
- Hospitalization time [ Time Frame: up to first post-procedure visit (around 1 month) ]Hospital stay (number of days)
- 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)
- Number of participants with stroke, neurological symptom or sign [ Time Frame: within 12 +/- 2 months ]Any new stroke, neurological symptom or sign
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| 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)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 17, 2019 | ||||||||
| First Posted Date ICMJE | May 3, 2019 | ||||||||
| Last Update Posted Date | April 17, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 18, 2019 | ||||||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices | ||||||||
| Official Title ICMJE | The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
250 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 2024 | ||||||||
| Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03936647 | ||||||||
| Other Study ID Numbers ICMJE | 2020-8330 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM) | ||||||||
| Study Sponsor ICMJE | Centre hospitalier de l'Université de Montréal (CHUM) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Centre hospitalier de l'Université de Montréal (CHUM) | ||||||||
| Verification Date | April 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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