NCT05024292招募中不适用
Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy
Shanghai Jiao Tong University Affiliated Sixth People's Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- functional independence
研究概览
简要总结
To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.
详细描述
For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
- •Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
- •Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
- •Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
- •The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt
排除标准
- •Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
- •Patients underwent rescue angioplasty or stenting after thrombectomy
结局指标
主要结局
functional independence
时间窗: 3 month
mRS 0-2
次要结局
- excellent functional independence(3 month)
- early therapeutic response(on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5)
- Mortality(3 month)
- hemorrhagic transformation(24 hours after treatment)
- Symptomatic intracerebral hemorrhage (sICH)(24 hours after treatment)
- malignant infarction(24 hours after treatment)
研究者
Yueqi Zhu
Associated dean of the radiology
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
研究点 (2)
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