Recruiting

Endovascular Intervention

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04261478

Conditions

Stroke, Acute

Carotid Stenosis

Carotid Artery Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carotid artery stenting

Antiplatelet Agents

Study Details

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).

Conditions

Stroke, Acute

Carotid Stenosis

Carotid Artery Diseases

Study ID

NCT04261478

Start date

Aug 31, 2020

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

458 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Acute Stenting

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.

no intervention: No Acute Stenting

All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.

Interventions

Carotid 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.

Antiplatelet 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 is allowed while periprocedural IV Heparin is discouraged.

Primary outcome measure

  • Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) [ Time Frame: 90 days ± 14 days ]

Central Contacts and Locations

Central contacts

Alexandre Y Poppe, MD CM

5148908000alexandre.poppe.med@ssss.gouv.qc.ca

Imene Fahmi, MSc

5148908000easitoc.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Alexandre Y Poppe, MD CM

5148908000alexandre.poppe.med@ssss.gouv.qc.ca

Imene Fahmi, MSc

5148908000easitoc.chum@ssss.gouv.qc.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 14, 2026

Last verified

Mar, 2026

Keywords

  • Thrombectomy
  • Tandem occlusion
  • Carotid stenting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-14.