EASI-TOC

Endovascular Acute Stroke Intervention – Tandem OCclusion trial (EASI TOC): a trial of acute cervical internal carotid artery stenting during endovascular thrombectomy for anterior circulation stroke

o   Treatment – stenting or no stenting: Patients will be randomized to undergo acute ICA stenting during the thrombectomy procedure (either before or after intracranial thrombectomy, at the discretion of the treating physician) or to intracranial thrombectomy alone without ICA stenting.

o   Primary objective – To see if stenting is superior to no stenting with regards to functional outcome at 90 days

o   All baseline procedures are standard of care

o   Follow-ups – 90 days (in person or telephone, blinded) and 12 months (telephone)

Randomization Link: https://redcap.chumontreal.qc.ca/redcap/

Written consent with patient/SDM OR deferral of consent (requiring PI signature and independent physician signature)

*Study binders (with consent form) are located in the filing cabinet in front of green zone bed 14. 

*For any study related questions call Dr. Hawkes or Kiran (647-997-3492).

Inclusion Criteria:

• Acute ischemic anterior circulation stroke eligible for EVT, with or without 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

Exclusion Criteria:

• Pre-existing neurological impairment (mRS ≥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

4 EASY ENROLLING STEPS:

1. consent with patient or SDM or deferral of consent

2. randomize

3. Ask nurses to note down the maximum and minimum BP and HR during EVT

4. Order carotid imaging (CTA, MRA or carotid doppler) after 24 hours of randomization

TECHNICAL POINTS:

1. DSA must confirm 70%+ stenosis on the first run (pre EVT)

2. It does not matter what the % stenosis is after the intracranial occlusion is recanalized, as you may have “blasted” through

3.  Any stent can be used

4. Any antiplatelet regimen can be used (they recommend Integrillin if no TNK, but you decide)

5. EPD not mandated but can be used

Sunnycare Note: 

Patient was enrolled in the EASI-TOC Stroke Trial on [date] at [time]. They meet all inclusion and no exclusion criteria. Informed consent obtained from [patient/SDM/deferral] by [staff name]. Consent obtained prior to any study related procedures being performed. They have been advised of the risks and potential benefits and given adequate time to ask study related questions. No questions asked/no concerns. Consent obtained at [time]. Patient was randomized to the acute stenting arm/ no acute stenting arm. Further management will be determined by the treating teams.