EUCTR2010-023507-95-DE进行中(未招募)1 期
Basilar Artery International Cooperation Study - BASICS TRIA
BASICS Study Group0 个研究点目标入组 750 人开始时间: 2012年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Symptoms and signs compatible with ischemia in the basilar artery territory.
- •Basilar artery occlusion confirmed by CTA or MRA.
- •Age18 or older (i.e., candidates must have had their 18th birthday).
- •If IVT is considered as part of BMM, IVT has to be initiated within 4.5 hours of estimated time of basilar artery occlusion.
- •Initiation of IA therapy should be feasible within 6 hours of estimated time of BAO.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 350
排除标准
- •Pre-existing dependency with mRankin =3.
- •Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
- •Patients who require hemodialysis or peritoneal dialysis.
- •Other serious, advanced, or terminal illness.
- •Any other condition that the investigator feels would pose a significant hazard to the patient if IA therapy is initiated.
- •Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
- •Informed consent is not or cannot be obtained.
- •Imaging Exclusion Criteria
- •Lesion consistent with hemorrhage of any degree.
- •Significant cerebellar mass effect or acute hydrocephalus.
- •Bilateral extended brainstem ischemia.
研究者
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