NCT02419781终止不适用
Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism (RESCUE)-Japan Randomized Controlled Trial
Shinichi Yoshimura2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Assessment of modified Rankin Scale shift analysis at 90 days after onset
研究概览
简要总结
The aim of this study is to clarify the efficacy of the endovascular treatment for acute ischemic stroke patients with large vessel occlusion and are not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke patients who were treated with intravenous rt-PA therapy within 4.5 hours from onset and have persistent occlusion of IC and M1 proximal portion* confirmed by cerebral angiography.
- •*: M1 proximal portion means the segment of MCA within 5mm from the internal carotid bifurcation.
- •Patients who can receive endovascular treatment within 8 hours after the onset.
- •Patients whose DWI-ASPECTS was 5 points and more, or CT-ASPECT was 6 points and more just before cerebral angiography.
- •Patients whose NIHSS is between 8 and 29 points.
- •Patients who are between 20 and 85 years.
- •Gender does not matter.
- •Consent of this study participants must be obtained from patients or legal representative in writing.
排除标准
- •Patients whose neurological symptoms improved and NIHSS is eight points and less after intravenous rt-PA therapy.
- •Patients whose mRS was 3 points and more before the onset. 3)Patients with past history of lumbar puncture or arterial puncture that were difficult of hemostasis.
- •Patients with intracranial tumor
- •Patients with hypersensitivity to contrast agent.
- •Patients with serious renal disease.
- •Patients with malignant tumor.
- •Patients with pregnancy or suspect of pregnancy, or during lactation.
- •Patients with findings of acute myocardial infarction or pericarditis after myocardial infarction.
- •Patients who cannot be followed for 3 months.
- •Patients with past history of cerebral aneurysm, cerebral arteriovenous malformation, cerebral venous thrombosis, or moyamoya disease.
- •Patients with other occlusions besides ICA or M1 proximal portion.
- •Patients with aortic dissection complicating endovascular treatment.
- •Patients with tortuous arteries that prevent the navigation of the device to the target vessel.
- •Patients considered inappropriate to participate in the study.
研究组 & 干预措施
Group without endovascular treatment
Active Comparator
Group without additional endovascular treatment
干预措施: No endovascular therapy (Procedure)
Group with endovascular treatment
Active Comparator
Group with additional endovascular treatment
干预措施: Rescue endovascular therapy (Procedure)
结局指标
主要结局
Assessment of modified Rankin Scale shift analysis at 90 days after onset
时间窗: 90 days
次要结局
- The rate of mRS 0-2 at 90 days (+/- 10 days) after onset(90 days)
- Death within 90 days (+/- 10 days) after onset(90 days)
- Revascularization rates of the target vessel at 72 hours (+/- 8 hours) after onset(72 hours)
- Symptomatic intracranial hemorrhage within 72 hours (+/- 8 hours) after onset(72 hours)
- The difference of NIHSS score between pre-treatment and at 72 hours (+/- 8 hours) after onset(72 hours)
研究者
Shinichi Yoshimura
Professor
Hyogo Medical University
研究点 (2)
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