Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic stroke-a Prospective Multicenter Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,004
- 试验地点
- 1
- 主要终点
- Functional independence at 90 days (modified Rankin Scale of 0-2)
研究概览
简要总结
Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, funded by National Key R&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Functional independence at 90 days (modified Rankin Scale of 0-2)
时间窗: 90±7 days after enrollment
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure
时间窗: 12-36 hours after the procedure
Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration
Time from symptom onset to recanalization
时间窗: The end of the procedure
次要结局
- Recanalization rate after the first attempt(At baseline, during the procedure, after the first attempt of endovascular treatment)
- Changes in NIHSS score 24 hours after the procedure(24 hours after the procedure)
- Changes in NIHSS score 7 days after the procedure or at discharge(7 days after the procedure or discharge)
- Barthel index (BI) 90 days after the procedure(90±7 days after the procedure)
- Recanalization rate at the end of the procedure(at the end of the procedure)
- Changes in NIHSS score immediately after the procedure(within 2 hours after the procedure)
- EQ-5D 90 days after the procedure(90±7 days after the procedure)
- Parenchymal hematoma (PH2)(12-36 hours after the procedure)
- Any intracranial hemorrhage on imaging(12-36 hours after the procedure)
- All-cause mortality within 90 days(90±7 days after the procedure)
- Time from onset to arrival(At baseline, after arrival at the hospital)
- Time from arrival to imaging(At baseline, after taking any brain imaging)
- Time from imaging to puncture(At baseline, during the procedure, after successful groin puncture)
- Time from puncture to recanalization(At baseline, during the procedure, after successful recanalization)
研究者
Zhongrong Miao
Director, Department of interventional neurology
Beijing Tiantan Hospital