NCT04664946招募中不适用
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT): One Single Center, Safety and Feasibility Study
Hui-Sheng Chen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of server adverse events
研究概览
简要总结
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Major neurologic deficits: 6≤NIHSS≤20;
- •Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4);
- •Premorbid mRS 0 or 1;
- •Signed informed consent.
排除标准
- •Modified Rankin Score >2 caused by a history of prior stroke;
- •Patients who underwent intravenous thrombolysis or Endovascular treatment;
- •Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <80000/mm3;
- •Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- •Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- •Unsuitable for this clinical studies assessed by researcher.
研究组 & 干预措施
Intra-arterial administration of 3-n-butylphthalide
Experimental
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
干预措施: Intra-arterial administration of neuroprotective agents (Drug)
结局指标
主要结局
Proportion of server adverse events
时间窗: 48 hours
server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc.
次要结局
- Proportion of patients with modified Rankin Score 0 to 1(90 days)
- Proportion of patients with modified Rankin Score 0 to 2(90 days)
- Modified Rankin Score(90 days)
- Changes in cerebral edema(48 hours)
- All causes of death within 48 hours after the treatment(48 hours)
- Differences in serum factors levels in different artery region(0 hour)
- Decrease in national institutes of health stroke scale (NIHSS)(48 hours)
- Proportion of symptomatic intracranial hemorrhage (sICH)(48 hours)
- Proportion of intraparenchymal hemorrhage (PH1 and PH2)(48 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region
研究点 (2)
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