Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04261478

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-11-18

458

Participants Needed

1

Research Sites

339 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

M

McGill University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Acute ischemic stroke in the anterior circulation eligible for endovascular therapy
  • Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery
  • Neurological deficit considered disabling by patient or physician
  • Imaging showing salvageable brain tissue suitable for treatment
  • Groin puncture within 24 hours of stroke onset or last known normal
  • Tandem ipsilateral high-grade (70% or greater) cervical internal carotid artery stenosis or occlusion of presumed atherosclerotic origin
  • Provision of informed consent by patient or surrogate, or deferral of consent as allowed by ethics policies
Not Eligible

You will not qualify if you...

  • Pre-existing neurological impairment with modified Rankin score 3 or higher
  • Any condition preventing protocol adherence or 3-month follow-up
  • Known contraindication to endovascular therapy, angioplasty/stenting, or antiplatelet therapy
  • Tandem ipsilateral high-grade carotid stenosis or occlusion not confirmed by angiography
  • Carotid stenosis or occlusion caused by arterial dissection
  • Isolated cervical carotid occlusion without intracranial occlusion
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

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Research Team

A

Alexandre Y Poppe, MD CM

CONTACT

N

Nandy Simon, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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