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Endovascular Acute Stroke Intervention - Tandem OCclusion Trial (EASI-TOC)

Primary Purpose

Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carotid artery stenting
Antiplatelet Agents
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Thrombectomy, Tandem occlusion, Carotid stenting

Eligibility Criteria

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

Inclusion Criteria:

  • Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:

    • Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA)
    • A neurological deficit judged to be disabling by the patient and/or treating physician
    • Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT
    • Groin puncture within 24-hours of onset or last known normal
  • Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging
  • Informed consent from patient or surrogate or deferral of consent, according to local ethics policies

Exclusion Criteria:

  • Pre-existing neurological impairment (modified Rankin score ≥3)
  • Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely
  • Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy
  • Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography
  • Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection
  • Isolated cervical carotid occlusion without intracranial occlusion
  • Pregnancy

Sites / Locations

  • Centre Hospitalier de l'Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Acute Stenting

No Acute Stenting

Arm Description

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.

Outcomes

Primary Outcome Measures

Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.

Secondary Outcome Measures

Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)
Ordinal logistic regression for functional improvement by at least one mRS category at 90 days ("shift analysis") The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Median NIHSS score at 24 hours after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Median NIHSS score at 90 days after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score
Median mRS at 90 days after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Clinical efficacy outcome: Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia
Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia within 90 days (imaging as clinically indicated) A structured telephone questionnaire for verifying stroke-free status will be used and relevant imaging reviewed
Radiological efficacy outcome: Proportion of patients with complete or near-complete recanalization
Proportion of patients with complete or near-complete recanalization (mTICI 2b/3) at the end of the endovascular procedure. mTICI score (0,1,2,2a,2b,3) : Grade 0 : no perfusion Grade 1 : penetration with minimal perfusion Grade 2 : partial perfusion Grade 2a : partial filling of less than 1/2 of the vascular territory Grade 2b : partial filling 50-99% of the vascular territory Grade 3 : complete perfusion Independent imaging core laboratory
Radiological efficacy outcome: Proportion of patients with ICA thrombosis (with or without stent)
Proportion of patients with ICA thrombosis (with or without stent) within 90 days after stroke stent patency be evaluated by angiography at the end of the EVT procedure. Furthermore, follow-up carotid vascular imaging will be required between 1 and 90 days following stent placement in the context of usual care. Any non-invasive imaging modality will be allowed, with carotid doppler or CTA strongly recommended.
Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score
Median Montreal Cognitive Assessment (MoCA) score at 90 days after stroke The MoCA is a 30-point screening tool for cognitive dysfunction (score from 0 to 30 with lower scores indicating greater cognitive impairment). The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Clinical efficacy outcome: Rate of any recurrent stroke or retinal ischemia
Rate of any recurrent stroke or retinal ischemia at 12 months after stroke A structured telephone questionnaire for verifying stroke-free status will be used
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale (mRS) score
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 12 months after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.

Full Information

First Posted
February 3, 2020
Last Updated
November 8, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
McGill University, Laval University, Queen's University, University of Ottawa, McMaster University, University of Calgary, University of British Columbia, Dalhousie University, Canadian Stroke Consortium (CSC), University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04261478
Brief Title
Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
Acronym
EASI-TOC
Official Title
A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
McGill University, Laval University, Queen's University, University of Ottawa, McMaster University, University of Calgary, University of British Columbia, Dalhousie University, Canadian Stroke Consortium (CSC), University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc. Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking. EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).
Detailed Description
EASI-TOC is a phase III multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation). The trial will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days (measured using the Modified Rankin Scale). EASI-TOC will be conducted at 10-12 high-volume comprehensive stroke centres in Canada. 458 male and female adult (aged ≥ 18 years) patients will be enrolled. Patients will be randomized (1:1) to undergo acute ICA stenting during the thrombectomy procedure (either before or after intracranial thrombectomy, at the discretion of the treating physician) or to intracranial thrombectomy alone without ICA stenting. Deferred ICA intervention is allowed, if indicated. Randomization will be centralized and web-based. Stratification will be performed for use or not of IV alteplase. Patients will be treated acutely and followed up to one year. Our primary hypothesis assumes a greater proportion of patients with 90-day mRS 0-2 in the stenting group versus the no stenting group (55% versus 40%). Assuming a minimal clinically important difference of 15 % between groups experiencing no crossover, a total of 173 patients per group would be sufficient to detect this difference, with a power of 80 % and a significance level of 5 %. Taking into account a cross-over rate of 10% (5% in either direction) and a loss to follow-up of 5 %, the total sample size will increase to 450 patients. Primary analysis will be by Intention-to-treat. Pre-specified as-treated and sex-specific analyses will also be performed. Informed consent will be obtained from patients or their surrogate. Deferral of consent will be allowed if permitted by local ethics committees.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases
Keywords
Thrombectomy, Tandem occlusion, Carotid stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
Masking
Outcomes Assessor
Masking Description
Open-label, blinded endpoint (PROBE)
Allocation
Randomized
Enrollment
458 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Stenting
Arm Type
Active Comparator
Arm Description
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.
Arm Title
No Acute Stenting
Arm Type
No Intervention
Arm Description
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.
Intervention Type
Device
Intervention Name(s)
Carotid artery stenting
Other Intervention Name(s)
Stenting
Intervention Description
The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Agents
Intervention Description
The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors, periprocedural IV Heparin is discouraged.
Primary Outcome Measure Information:
Title
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
Description
The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Time Frame
90 days ± 14 days
Secondary Outcome Measure Information:
Title
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Description
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)
Description
Ordinal logistic regression for functional improvement by at least one mRS category at 90 days ("shift analysis") The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Description
Median NIHSS score at 24 hours after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Time Frame
24 hours ± 8 hours
Title
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Description
Median NIHSS score at 90 days after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score
Description
Median mRS at 90 days after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia
Description
Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia within 90 days (imaging as clinically indicated) A structured telephone questionnaire for verifying stroke-free status will be used and relevant imaging reviewed
Time Frame
90 days ± 14 days
Title
Radiological efficacy outcome: Proportion of patients with complete or near-complete recanalization
Description
Proportion of patients with complete or near-complete recanalization (mTICI 2b/3) at the end of the endovascular procedure. mTICI score (0,1,2,2a,2b,3) : Grade 0 : no perfusion Grade 1 : penetration with minimal perfusion Grade 2 : partial perfusion Grade 2a : partial filling of less than 1/2 of the vascular territory Grade 2b : partial filling 50-99% of the vascular territory Grade 3 : complete perfusion Independent imaging core laboratory
Time Frame
End of endovascular procedure
Title
Radiological efficacy outcome: Proportion of patients with ICA thrombosis (with or without stent)
Description
Proportion of patients with ICA thrombosis (with or without stent) within 90 days after stroke stent patency be evaluated by angiography at the end of the EVT procedure. Furthermore, follow-up carotid vascular imaging will be required between 1 and 90 days following stent placement in the context of usual care. Any non-invasive imaging modality will be allowed, with carotid doppler or CTA strongly recommended.
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score
Description
Median Montreal Cognitive Assessment (MoCA) score at 90 days after stroke The MoCA is a 30-point screening tool for cognitive dysfunction (score from 0 to 30 with lower scores indicating greater cognitive impairment). The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Time Frame
90 days ± 14 days
Title
Clinical efficacy outcome: Rate of any recurrent stroke or retinal ischemia
Description
Rate of any recurrent stroke or retinal ischemia at 12 months after stroke A structured telephone questionnaire for verifying stroke-free status will be used
Time Frame
1 year ± 60 days
Title
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale (mRS) score
Description
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 12 months after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Time Frame
1 year ± 60 days
Other Pre-specified Outcome Measures:
Title
Safety outcome: Proportion of patients with any intracranial hemorrhage (ICH)
Description
Proportion of patients with any intracranial hemorrhage on follow-up imaging at 24 hours Independent imaging core laboratory
Time Frame
24 hours ± 8 hours
Title
Safety outcome: Proportion of patients with a symptomatic intracranial hemorrhage (sICH)
Description
Proportion of patients with symptomatic intracranial hemorrhage (sICH) within 72 hours of EVT ECASS-2 definition. Imaging core laboratory.
Time Frame
24 hours ± 8 hours
Title
Safety outcome: Proportion of patients with death of any cause
Description
All-cause mortality at 90 days
Time Frame
90 days ± 14 days
Title
Safety outcome: Proportion of patients with procedural complications
Description
Procedural complications, including: vessel perforation, iatrogenic vessel dissection, embolization into a previously unaffected artery, access site complications
Time Frame
End of endovascular procedure
Title
Safety outcome: Type of procedural complications
Description
Procedural complications, including: vessel perforation, iatrogenic vessel dissection, embolization into a previously unaffected artery, access site complications
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Proportion of patients with stenting performed after thrombectomy
Description
Timing of ICA stenting relative to intracranial thrombectomy (before/anterograde or after/retrograde)
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Description of type and route of administration of antiplatelet agents used peri-interventionally
Description
Antiplatelet and/or anticoagulant regimens used peri-interventionally: aspirin, clopidogrel, GP2b3a inhibitors, Heparin, other and route of administration: oral, rectal, intravenous, intra-arterial
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Proportion of patients for whom an embolic protection device was used
Description
Use of distal or proximal embolic protection among patients undergoing stenting
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Proportion of patients with internal carotid artery pseudo-occlusions confirmed on angiography
Description
Proportion of patients with presumed internal carotid artery tandem occlusion on non-invasive imaging (CTA or MRA) having no tandem occlusion on conventional angiography (pseudo-occlusions) Patients with no confirmed tandem lesion on angiography will be included in the screening log but not randomized in the trial
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Proportion of patients with delayed carotid revascularization
Description
The proportion of patients in the no stent group undergoing deferred ICA revascularization and the type of revascularization (endarterectomy or stenting) used, within 12 months after stroke
Time Frame
1 year ± 60 days
Title
Tertiary outcome: Type of delayed carotid revascularization
Description
T he type of revascularization (endarterectomy or stenting) used in patients in the no stent group undergoing deferred ICA revascularization, within 12 months after stroke
Time Frame
1 year ± 60 days
Title
Tertiary outcome: Minimum and maximum systolic and diastolic intraprocedural blood pressure (mmHg)
Description
Minimum and maximum blood pressure (systolic and diastolic, mmHg) during EVT procedure Derived from procedural vital sign records
Time Frame
End of endovascular procedure
Title
Tertiary outcome: Minimum and maximum intraprocedural heart rate (beats per minute)
Description
Minimum and maximum intraprocedural heart rate (beats per minute) during EVT procedure Derived from procedural vital sign records
Time Frame
End of endovascular procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis: Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA) A neurological deficit judged to be disabling by the patient and/or treating physician Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT Groin puncture within 24-hours of onset or last known normal Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging Informed consent from patient or surrogate or deferral of consent, according to local ethics policies Exclusion Criteria: Pre-existing neurological impairment (modified Rankin score ≥3) Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection Isolated cervical carotid occlusion without intracranial occlusion Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Y Poppe, MD CM
Phone
5148908000
Ext
26260
Email
alexandre.poppe.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nandy Simon, BSc
Phone
5148908000
Ext
26242
Email
nandy-shelwine.simon.chum@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Y Poppe, MD CM
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
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
Alexandre Y Poppe, MD CM
Phone
5148908000
Ext
26268
Email
alexandre.poppe.med@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Nandy Simon, BSc
Phone
5148908000
Ext
262642
Email
nandy-shelwine.simon.chum@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon completion of the EASI-TOC Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) imaging data; (4) serious adverse events. These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
IPD Sharing Time Frame
These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
IPD Sharing Access Criteria
These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
Links:
URL
https://www.easitoc-study.ca/
Description
Study website

Learn more about this trial

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

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