Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Feb 6, 2020

Keywords

ClinConnect Summary

**Trial Summary: Endovascular Acute Stroke Intervention - Tandem Occlusion Trial**

The EASI-TOC trial is researching the best treatment for patients who have a specific type of stroke called tandem occlusion. This means that there is a blockage in the brain’s blood vessels, as well as a significant narrowing or blockage in the carotid artery, which supplies blood to the brain. The goal of the study is to find out if placing a stent (a small tube that opens up the artery) in the carotid artery, in addition to removing the blockage in the brain, leads to better recovery compared to just removing the blockage in the brain alone. This trial will help doctors understand the best approach to treat these patients and improve their chances of recovery in the long term.

To be eligible for this study, participants should be experiencing an acute ischemic stroke in the front part of the brain and have a significant blockage in the carotid artery on the same side. They must also be able to give consent (or have someone do it for them) and need to have had their symptoms start within the last 24 hours. However, individuals with pre-existing neurological issues, certain health conditions, or who are pregnant will not be able to participate. If you choose to take part, you will be randomly assigned to either receive the stent or not, and the researchers will follow your progress over the next 90 days to see how you recover. Your involvement could contribute to important findings that may help others with similar conditions in the future.

Gender

ALL

Eligibility criteria

• 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