Multicenter randomised clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands for late arrivals

Maastricht University Medical Center0 个研究点目标入组 535 人开始时间: 2017年12月11日最近更新: 2024年7月8日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31915166/ protocol (added 16/02/2021) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33627168/ protocol (added 26/02/2021) 2023 Results article in https://doi.org/10.1016/s0140-6736(23)00575-5 (added 03/04/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38909624/ 2-year follow-up (added 25/06/2024)

•1. Clinical diagnosis of acute ischemic stroke
•2. Caused by proximal intracranial anterior circulation occlusion (distal intracranial carotid artery or middle (M1/M2) cerebral artery confirmed by neuro-imaging (CTA or MRA)
•3. Presence of poor*, moderate or good collateral flow as shown by neuroimaging (CTA)
•4. CT or MRI ruling out intracranial hemorrhage
•5. Start of IA treatment (groin puncture) possible between 6 and 24 hours after symptom onset or last seen well < 24 hours including wake-up strokes
•6. A score of at least 2 on the NIH Stroke Scale
•7. Age of 18 years or older
•*Inclusion and randomization will be restricted to patients with moderate or good collaterals when 100 patients with poor collaterals have been included in the study

•1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
•2. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of large recent infarction on neuroimaging in the territory of the middle cerebral antery
•3. Clinical evidence of hemorrhagic diathesis, confirmed by an INR > 3 and/or a platelet count < 40 x 109/L and/or an APTT > 50 sec
•4. Clearly demarcated hypodensity in >1/3 of the middle cerebral artery territory, consistent with current symptoms
•5. Participation in trials other than current and MR ASAP

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