NL-OMON55450招募中3 期
Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in The Netherlands for Late Arrivals: MR CLEAN LATE - MR CLEAN LATE
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •o clinical diagnosis of acute ischemic stroke,
- •o caused by proximal intracranial anterior circulation occlusion (distal
- •intracranial carotid artery or middle (M1/M2 ) cerebral artery confirmed by
- •neuro-imaging (CTA),
- •o and presence of poor*, moderate or good collateral flow as shown by
- •neuro-imaging (CTA)
- •o CT or MRI ruling out intracranial hemorrhage,
- •o Start of IA treatment (groin puncture) possible between 6 and 24 hours or
- •last seen well < 24 hours including wake-up strokes,
- •o a score of at least 2 on the NIH Stroke Scale
- •o age of 18 years or older
- •o Written informed consent (deferred)
- •* Inclusion and randomization will be restricted to patients with moderate or
- •good collaterals when 100 patients with poor collaterals have been included in
排除标准
- •o Pre-stroke disability which interferes with the assessment of functional
- •outcome at 90 days, i.e. mRS >2
- •o cerebral infarction in the previous 6 weeks with residual neurological
- •deficit or signs of recent infarction on neuroimaging in the territory of the
- •middle cerebral artery
- •o INR exceeding 3.0*
- •o platelet count < 40 x 109/L*
- •o APTT > 50 sec*
- •o visible infarction in > 1/3 of the territory of the middle cerebral artery
- •o participation in trials other than current and MR ASAP.
- •o ICA-T/M1 occlusion, NIHSS >=10, infarct core <=25ml and a mismatch ratio total
- •ischemic volume/ infarct core >=2 (patient is eligible for direct EVT treatment,
- •based on DAWN/DEFUSE 3 patient profile)
- •Inclusion in other intervention trials during the study period is not allowed
- •* In case there is no clinical indication to test for hemorrhagic diathesis, it
- •may be assumed that the INR, APTT and platelet count are within these limits.
研究者
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