Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Carotid artery stenting
DeviceThe 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
DrugThe 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 is allowed while periprocedural IV Heparin is discouraged.
Treatment groups
458 Participants
are divided into 2 treatment groupsGroup A: Acute StentingActive comparator 2 interventions
Group B: No Acute StentingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
90 days ± 14 daysSecondary outcomes
1
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
Time frame
90 days ± 14 days2
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.
Time frame
90 days ± 14 days3
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)
Time frame
24 hours ± 8 hours4
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)
Time frame
90 days ± 14 daysOther outcomes
1
Safety outcome: Proportion of patients with any intracranial hemorrhage (ICH)
Proportion of patients with any intracranial hemorrhage on follow-up imaging at 24 hours Independent imaging core laboratory
Time frame
24 hours ± 8 hours2
Safety outcome: Proportion of patients with a symptomatic intracranial hemorrhage (sICH)
Proportion of patients with symptomatic intracranial hemorrhage (sICH) within 72 hours of EVT ECASS-2 definition. Imaging core laboratory.
Time frame
24 hours ± 8 hours3
Safety outcome: Proportion of patients with death of any cause
All-cause mortality at 90 days
Time frame
90 days ± 14 days4
Safety outcome: Proportion of patients with procedural complications
Procedural complications, including: vessel perforation, iatrogenic vessel dissection, embolization into a previously unaffected artery, access site complications
Time frame
End of endovascular procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
McGill University
Collaborator
Laval University
Collaborator
Queen's University
Collaborator
University of Ottawa
Collaborator
McMaster University
Collaborator
University of Calgary
Collaborator
University of British Columbia
Collaborator
Dalhousie University
Collaborator
Health Sciences North Research Institute
Collaborator
University of Toronto
Collaborator
University of Alberta
Collaborator
Canadian Stroke Consortium (CSC)
Collaborator
University of Manitoba
Collaborator
Université de Sherbrooke
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Brain Canada
Collaborator
Heart and Stroke Foundation of Canada
Collaborator
Source ClinicalTrials.gov