Clinical Trial

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

Study acronym: EASI-TOC
Recruiting
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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).
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06 -> 2027-05 2026-08-15
minor Completion pushed: 2027-03 -> 2027-10 2026-08-15
Trial Details
NCT Number NCT04261478
Lead 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, Health Sciences North Research Institute, University of Toronto, University of Alberta, Canadian Stroke Consortium (CSC), University of Manitoba, Université de Sherbrooke, Canadian Institutes of Health Research (CIHR), Brain Canada, Heart and Stroke Foundation of Canada
Conditions Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases
Enrollment 458 participants
Start Date 2020-08-31
Primary Completion 2027-05 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-14