NCT00123266终止2 期
An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 7
- 主要终点
- Recanalization rate
研究概览
简要总结
The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.
详细描述
Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angiographically documented vertebrobasilar artery occlusion
- •Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
- •Age 18-75 (inclusive).
排除标准
- •Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
- •Rapidly improving neurologic signs at any time before initiation of study drug administration.
- •Known contrast agent-sensitivity
- •Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
- •History of stroke within the previous 6 weeks.
研究组 & 干预措施
Active
Experimental
干预措施: Microplasmin (Drug)
结局指标
主要结局
Recanalization rate
时间窗: Day-7, Day-30 and Day-90
次要结局
- Clinical assessment(Day-7, Day-30 and Day-90)
研究者
研究点 (7)
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