Table 1.
Inclusion criteria | |
---|---|
1 | Acute ischemic stroke clinically eligible for immediate EVT, including both subjects treated and subjects not treated with thrombolytic therapy according to current standard of care. All patients eligible for intravenous thrombolysis must be thrombolyzed without delay |
2 | Age ⩾ 18 years at the date of randomization |
3 | Time from onset (or last-seen-well) to randomization < 12 h a |
4 | Disabling stroke defined as follows: (a) baseline National Institutes of Health Stroke Scale (NIHSS) score > 5 at the time of randomization (b) baseline NIHSS 3–5 with disabling deficit (e.g. hemianopia, aphasia, loss of hand function) as determined by the attending physician in context of the patient’s life situation at the time of randomization |
5 | Confirmed symptomatic and endovascularly treatable MeVO based on neurovascular non-invasive imaging (CTA or MRA) |
6 | Clinical deficit commensurate with MeVO location |
7 | Informed consent (process is site-specific) |
Exclusion criteria | |
1 | Alberta Stroke Program Early CT Score ⩽ 5 |
2 | Lack of salvageable brain tissue, defined as one of the following, depending on the imaging modality of the participating site: (a) NCCT + mCTA: Well demarcated hypodensity in the majority of the brain parenchyma supplied by the occluded vessel or absence of collaterals in the affected territory on the delayed phases of the mCTA (b) NCCT + (m)CTA/spCTA ± CTP: Lack of core:penumbra mismatch (if the CTP is uninterpretable, e.g. due to motion artifacts, apply exclusion criteria from 2(a). If spCTA rather than mCTA is performed, and the CTP was not performed, or was performed but is uninterpretable, score collaterals on spCTA and apply exclusion criteria from 2(a). If NCCT + mCTA + CTP are all performed, either the core:penumbra mismatch exclusion criteria from 2(b) or the exclusion criteria from 2(a) can be used) (c) MRI (DWI, MRA, ± MRP): Diffusion restriction in the majority of the brain parenchyma supplied by the occluded vessel or if MR perfusion is performed: lack of core:penumbra mismatch |
3 | Any evidence of intracranial hemorrhage on qualifying imaging |
4 | Patients living in a nursing home or requiring daily nursing care or assistance with activities of daily living |
5 | Patient has a major co-morbid illness, such as moderate or severe dementia, advanced cancer, advanced heart failure and so on, such that they are unlikely to be able to complete follow-up or they are unlikely to achieve the primary outcome due to the underlying illness (rather than the stroke or its treatment) |
6 | Pregnancy: female with positive urine or serum beta human chorionic gonadotropin (β-hCG) test |
7 | Participation in another clinical therapeutic intervention trial |
EVT: endovascular treatment; MRA: MR-angiography; NCCT: non-contrast CT (computed tomography); CTP: CT perfusion; MRI: magnetic resonance imaging; DWI: diffusion-weighted MRI; MRP: MR perfusion; OR: odds ratio; NIHSS: National Institutes of Health Stroke Scale; mCTA: multiphase CT angiography; spCTA: single phase CT angiography.
This choice was made based on time-windows used previously in the ESCAPE, ESCAPE-NA1 and ESCAPE-NEXT trials.