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
Qualifiers
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
Treatments tested in this trial
- Carotid artery stenting
- Antiplatelet Agents
Treatment groups
Sponsors and collaborators
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