EASI



Protocol Summary

The proposed study is a multicentric randomized controlled clinical care trial.

The primary objective is to determine whether standard stroke treatment with mechanical thrombectomy is superior to standard stroke treatment alone in the 6 hours following the onset of symptoms in patients presenting with a high-severity cerebrovascular accident (CVA) (NIHSS≥10) due to proximal cerebral artery occlusion.  Patients may be recruited beyond the 6-hour time window when there is, in the opinion of the physician, significant mismatch between the neurological deficit and imaging findings.

The study hypothesizes an absolute difference of 15% at 3 months in the primary outcome, defined as modified Rankin Score (mRS) ≤ 2, from 25 to 40% between the two groups at 3 months.

480 patients (240 in each group) presenting within 6 hours of onset of a severe CVA will be randomized into each arm with a 1 to 1 ratio. For patients in the thrombectomy group, the intervention will preferably start within 5 hours of CVA onset. Symptoms-imaging mismatch may be used in the patients in which symptoms onset time is unknown (unwitnessed CVA) or for wake-up strokes, or for occlusion of the vertebro-basilar system.

A sub-study embedded within the principal study aims to determine the best approach to tandem lesions (proximal cerebral artery occlusion in the setting of cervical carotid occlusion or severe stenosis).  Determining whether to concurrently treat the proximal cerebral vessels occlusion, or leave it for later aggressive medical therapy or endarterectomy as per best available evidence will be the primary objective of this substudy.

The primary endpoint is a clinical measure, the percentage of patients that are autonomous at 3 months (mRS ≤ 2).  The secondary endpoint is the existence of hemorrhagic complications at 24 hours and neurological status at 3 months (Barthel score and mRS).

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Guylaine Gevry,
Dec 2, 2015, 11:38 AM
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Guylaine Gevry,
Dec 2, 2015, 11:37 AM
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Guylaine Gevry,
Aug 9, 2016, 11:54 AM
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