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

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

458 Participants
are divided into 2 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