跳至主要内容
临床试验/NCT00507806
NCT00507806终止1 期

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

ImaRx Therapeutics0 个研究点开始时间: 2005年3月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
终止
发起方
主要终点
Incidence of symptomatic intracranial hemorrhage

研究概览

简要总结

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
  • tPA eligible
  • Occlusion of the middle cerebral artery

排除标准

  • Right to left cardiac shunt
  • Uncontrolled hypertension
  • Absent temporal windows

结局指标

主要结局

Incidence of symptomatic intracranial hemorrhage

时间窗: 72 hours

次要结局

  • Complete recanalization of the occluded artery (TIBI 4-5)(End of treatment)
  • NIHSS score of 0-2(24 hours)
  • Favorable outcome (modified Rankin Scale or NIHSS 0-1)(3 months)

研究者

发起方
ImaRx Therapeutics
申办方类型
Industry

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