Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
NCT ID: NCT04261478
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
458 participants
INTERVENTIONAL
2020-08-31
2027-03-31
Brief Summary
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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).
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Detailed Description
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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 and for enrolling site.
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, sex-specific and subgroup 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acute Stenting
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.
Carotid artery stenting
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.
Antiplatelet Agents
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.
No Acute Stenting
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.
No interventions assigned to this group
Interventions
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Carotid artery stenting
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.
Antiplatelet Agents
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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McGill University
OTHER
Laval University
OTHER
Queen's University
OTHER
University of Ottawa
OTHER
McMaster University
OTHER
University of Calgary
OTHER
University of British Columbia
OTHER
Dalhousie University
OTHER
Health Sciences North Research Institute
OTHER
University of Toronto
OTHER
University of Alberta
OTHER
Canadian Stroke Consortium (CSC)
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Alexandre Y Poppe, MD CM
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Study website
Other Identifiers
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MP-02-2020-8614
Identifier Type: -
Identifier Source: org_study_id
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