NCT01895634已完成不适用
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Johnson & Johnson K.K. Medical Company2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Proportion of Patients Who Have Recanalization
研究概览
简要总结
The main objective of this study is to document that the thrombectomy catheter (Rev-01) is effective and safe when used for revascularization in subjects with acute ischemic stroke within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom treatment with IV t-PA has been ineffective.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject presenting with clinical signs and symptoms consistent with a diagnosis of acute ischemic stroke
- •Onset of symptom is within 8 hours prior to treatment with Rev-01
- •Treatment with IV t-PA is ineligible or ineffective
- •Occluded (presenting TICI score of 0 or 1) M1 or M2 of MCA, basilar or vertebral artery, or intracranial segment of ICA, confirmed by angiography that it is accessible to the Rev-01
- •NIHSS score is 8-30
- •Prior to new focal disabling neurologic deficit, mRS score was 0-2
- •Age from 20 y.o. to 85 y.o.
- •Written informed consent to participate by subject or legal representative
排除标准
- •Subject presenting; ICA dissection, Angiitis, Arterial tortuosity that would prevent the device from reaching the target vessel, Arterial stenosis > 50% that would prevent the device from reaching the target vessel, Evidence of acute intracranial hemorrhage, Evidence of mass effect or intracranial tumor, Evidence of extended early ischemic changes
- •Subject with more than two major artery occluded
- •Known sensitivity or ineligible to radiographic agent, or metallic allergy
- •Administration of dabigatran or heparin within 48 hours preceding the onset of stroke and have an elevated APTT or PTT above twice of the normal range for the laboratory at presentation
- •Known bleeding diathesis of current use of oral anticoagulants (e.g., warfarin sodium) with International Normalized Ration (INR) > 3
- •Platelet count < 30,000/mm3
- •Glucose < 50 mg/dL
- •Severe sustained hypertension (SBP > 185mmHG or DBP > 110mmHG) refractory to pharmacological management
- •Life expectancy of less than 90 days
- •Pregnancy or females who are lactating
- •Current participation in an investigational drug or device study
- •Otherwise determined by investigator to be medically unsuitable for participation
结局指标
主要结局
Proportion of Patients Who Have Recanalization
时间窗: immediately post procedure
Proportion of subjects who had recanalization, TICI 2a or better
次要结局
- Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure(90 days post procedure)
- Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)(24-hour post procedure)
- All Cause Mortality(90 days post-procedure)
- Proportion of Subject Who Have Clot Migration/Embolization(immediately post procedure)
研究者
研究点 (2)
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