NCT04261478 Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

Eligibility & Interventions

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This trial targets 458 participants in total. It began in 2020-08-31 with a primary completion date of 2026-06.

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).

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

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