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临床试验/NCT00478478
NCT00478478已完成不适用

Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Stryker Neurovascular1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Post-procedure revascularization success

研究概览

简要总结

Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:

  • Post-procedure revascularization success
  • 90-day mRS 0-2
  • 90-day mortality

详细描述

The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.

The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. "Treated" is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke
  • Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place

排除标准

  • There are no exclusion criteria for this protocol

结局指标

主要结局

Post-procedure revascularization success

时间窗: post-procedure

次要结局

  • 90-day mortality(90-day)
  • NIHSS change from baseline to 24-hours(24-hour)
  • 90-day mRS outcomes(90-day)

研究者

发起方
Stryker Neurovascular
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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