Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Acute ischemic stroke clinically eligible for immediate EVT.
2. Age ≥ 18 years at the date of randomization.
3. Time from onset (or last-seen-well) to randomization < 12 hours.
4. Disabling stroke defined as follows:
1. baseline National Institutes of Health Stroke Scale (NIHSS) score > 5 at the time of randomization;
2. NIHSS 3-5 with disabling deficit (eg. hemianopia, aphasia, loss of hand function) as determined by the attending physician in context of the patient's life situation.
5. Confirmed symptomatic and endovascularly treatable MeVO based on neurovascular non-invasive imaging (CTA or MRA), at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P2 or P3 segment.
6. . Clinical deficit commensurate with MeVO occlusion location.
7. . Signed informed consent, two-physician consent, or deferral of consent where approved.
Exclusion Criteria:
8. ASPECTS ≤ 5.
9. The following depend on the imaging modality of the participating site:
9a. 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; OR
9b. 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 9a. If single-phase CTA rather than mCTA is performed, and the CTP was not performed, or CTP was performed but is uninterpretable, score collaterals on single-phase CTA and apply exclusion criteria from 9a. If NCCT + mCTA + CTP are all performed, either the core:penumbra mismatch exclusion criteria from 9b or the exclusion criteria from 9a can be used); OR
9c. 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
10. Any evidence of intracranial hemorrhage on qualifying imaging
11. Patients living in a nursing home or requiring daily nursing care or assistance with activities of daily living
12. Patient has a major co-morbid illness, such as moderate or severe dementia, advanced cancer, advanced heart failure etc., 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)
13. Pregnancy: female with positive urine or serum beta human chorionic gonadotropin (β-hCG) test
14. Participation in another clinical therapeutic intervention trial
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/9/24. Questions regarding updates should be directed to the study team contact.