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Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

RecruitingNAAges 18 Years - anyAllCentre hospitalier de l'Université de Montréal (C…
NCT04261478 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Carotid artery stenting
  • Antiplatelet Agents
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Where

1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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