NCT01210729已完成2 期
Mechanical Recanalization With Flow Restoration in Acute Ischemic Stroke (ReFlow Study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)
研究概览
简要总结
The objective of this study is to collect data on the use of the SOLITAIR FR device for treatment of acute ischemic stroke with large artery occlusion i.e. to investigate, whether the application of SOLITAIR is a safe and feasible method for interventional recanalization of large vessels with favorable patient outcome in acute stroke therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years
- •Acute ischemic stroke with occlusion if ICA, MCA, VA or BA (TICI 0 or 1 flow) within the first 6 hours
排除标准
- •Rapidly improving neurological signs
- •NHISS>30 or coma
- •Female patients, who are pregnant or lactating
- •Use of warfarin anticoagulation with INR > 1.5
- •Platelet count < 30,000
- •Glucose < 50 mg/dL
- •Life expectancy of less than 90 days
- •Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
- •CT showing hypodensity on presentation
结局指标
主要结局
Overall frequency of favourable clinical outcome (modified Rankin Scale 0 to 2), and unfavourable clinical outcome or death (modified Rankin Scale 3 to 6)
时间窗: Day 90
次要结局
- Time between arterial puncture and TICI 2b or 3 recanalization(Day 0)
- Excellent functional clinical outcome (modified Rankin Scale 0 or 1)(Day 90)
- All causes of mortality(Day 90)
- Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS) during the first 24 hours after treatment.(Day 1)
- Symptomatic intracranial haemorrhages up to 24 hours after treatment defined as homogeneous areas of haemorrhage, with or without mass effect or intraventricular extension with neurological deterioration(Day 1)
- Time between arterial puncture and Flow Restoration(Day 0)
- Arterial recanalization of occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI)score of 2b or 3 following the use of the SOLITAIRE FR Device(Day 0)
- Number of SOLITAIRE device runs until recanalization(Day 0)
- Number of patients with and degree of stenosis in the treated artery 90 days after recanalization with SOLITAIRE(Day 90)
- Number of patients in which thrombus material was preserved(Day 0)
- Histological examination of the thrombus material in correlation with TICI 2b or 3 recanalization and favorable clinical outcome(Day 1)
- Overall frequency of modified Rankin Scale 0 to 2 at 30 days(Day 30)
研究者
研究点 (2)
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