Acute ischemic stroke
Conditions
Brief summary
Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver.
Detailed description
mRS 0 to 1 at 90 days, mRS 0 to 2 at 90 days, Any EVT procedure performed, defined as at least one EVT pass, eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer), eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)., Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT)., Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours., EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L)., Parenchymal hemorrhage type 1 or 2 assessed according to the Heidelberg classification on a follow-up brain imaging within 36 hours of randomization., Any intracranial hemorrhagic transformation according to the Heidelberg classification on a brain imaging within 36 hours of randomization that is causally associated with an NIHSS increase ≥ 4 points, All-cause death at 90 days
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score, merging categories 5-6 in ordinal analysis. The mRS will be centrally collected by trained professionals blinded to the treatment allocation, based on a phone interview with the patient and/or caregiver. | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS 0 to 1 at 90 days, mRS 0 to 2 at 90 days, Any EVT procedure performed, defined as at least one EVT pass, eTICI score of 2b, 2c or 3 on the first angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer), eTICI score of 2b, 2c or 3 on the final angiographic run of the endovascular procedure or revised AOL 2b-3 on non-invasive arterial imaging obtained within 36 hours of randomization if the digital subtraction angiography was not performed or uninterpretable (e.g. clinical improvement during transfer)., Change in NIHSS score between baseline (time of randomization) and arrival at EVT-capable stroke center (before EVT)., Improvement in NIHSS score between baseline (time of randomization) and 24-36 hours of ≥8 points or an NIHSS score ≤1 at 24-36 hours., EuroQol 5-Dimension 3-Level qu | — |