RecruitingNot ApplicableNCT04261478

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

458 participants

Start Date

Aug 31, 2020

Study Type

INTERVENTIONAL

Conditions

Stroke, Acute Carotid Stenosis Carotid Artery Diseases

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria7

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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Interventions

DEVICECarotid artery stenting

The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.

DRUGAntiplatelet Agents

The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors, periprocedural IV Heparin is discouraged.