The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices - Clinical Trial for Intracranial Aneurysm | NCT03936647

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

WEB embolization device

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring intracranial aneurysm, cerebral aneurysm, brain aneurysm, unruptured cerebral aneurysm, ruptured cerebral aneurysm, WEB embolization device, embolization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier de l'Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard conventional treatment (surgical or endovascular)

WEB embolization device

Arm Description

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.

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Outcomes

Primary Outcome Measures

Number of participants with imaging showing that index aneurysm has reached complete or near occlusion

complete or near complete occlusion of the aneurysm

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

Secondary Outcome Measures

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

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

Number of incidences of successful or unsuccesful patency of parent arteries using imaging

Analysis of imaging to judge the patency of the parent arteries

Number of peri-operative complications

Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)

Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging

Angiographic outcome (invasive or non-invasive imaging) results

Hospitalization time

Hospital stay (number of days)

Incidence of discharge destination by type

Discharge disposition (home; other hospital; rehabilitation facility; death)

Number of participants with stroke, neurological symptom or sign

Any new stroke, neurological symptom or sign

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

Full Information

NCT ID

NCT03936647

First Posted

April 17, 2019

Last Updated

July 4, 2023

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT03936647

Brief Title

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

Acronym

RISE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 18, 2019 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Standard best conventional treatment option (surgical or endovascular) vs WEB embolization device

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard conventional treatment (surgical or endovascular)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

WEB embolization device

Arm Type

Experimental

Arm Description

Endovascular treatment with WEB, including standard management of thrombo-embolic risk

Intervention Type

Procedure

Intervention Name(s)

surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

WEB embolization device

Intervention Description

WEB embolization device

Primary Outcome Measure Information:

Title

Number of participants with imaging showing that index aneurysm has reached complete or near occlusion

Description

complete or near complete occlusion of the aneurysm

Time Frame

1 year from procedure

Title

Number of patients with a modified Rankin Score (mRS) below or equal to 2

Description

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

Time Frame

1 year from procedure

Secondary Outcome Measure Information:

Title

Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2

Description

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

Time Frame

within 1 week post-procedure, 1-3 months, and 12 months post-treatment

Title

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)

Description

Successful WEB deployment / aneurysm clipping / aneurysm coiling

Time Frame

within 1 hour from procedure

Title

Number of incidences of successful or unsuccesful patency of parent arteries using imaging

Description

Analysis of imaging to judge the patency of the parent arteries

Time Frame

within 1 hour from procedure

Title

Number of peri-operative complications

Description

Peri-operative complications (such as ischemic strokes and intracranial hemorrhages)

Time Frame

≥5 days

Title

Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging

Description

Angiographic outcome (invasive or non-invasive imaging) results

Time Frame

12 +/- 2 months

Title

Hospitalization time

Description

Hospital stay (number of days)

Time Frame

up to first post-procedure visit (around 1 month)

Title

Incidence of discharge destination by type

Description

Discharge disposition (home; other hospital; rehabilitation facility; death)

Time Frame

up to first post-procedure visit (around 1 month)

Title

Number of participants with stroke, neurological symptom or sign

Description

Any new stroke, neurological symptom or sign

Time Frame

within 12 +/- 2 months

Title

Number of index aneurysms necessitating or having received retreatment due to re-occurence

Description

Re-treatment of the index aneurysm as judged by imaging and interventionists neurosurgeons due to incomplete occlusion or hemorrhage

Time Frame

Within 12 +/- 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Raymond, MD

Phone

514-890-8000

Ext

27235

Email

jraymond.nri@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Guylaine Gevry, BSc

Phone

514-890-8000

Ext

27235

Email

guylaine.gevry.chum@ssss.gouv.qc.ca

Facility Information:

Facility Name

Centre Hospitalier de l'Université de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guylaine Gevry, BSc

Phone

514-890-8000

Ext

27235

Email

guylaine.gevry.chum@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Ruby Klink, PhD

Phone

514-890-8000

Ext

26359

Email

Ruby.Klink@crchum.qc.ca

First Name & Middle Initial & Last Name & Degree

Jean Raymond, MD

First Name & Middle Initial & Last Name & Degree

Daniel Roy, MD

First Name & Middle Initial & Last Name & Degree

Alain Weill, MD

First Name & Middle Initial & Last Name & Degree

Daniela Iancu, MD

12. IPD Sharing Statement

Plan to Share IPD

No

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

Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial