跳至主要内容
临床试验/NCT00785161
NCT00785161已完成不适用

Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System

Penumbra Inc.1 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2008年10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
Penumbra Inc.
入组人数
289
试验地点
1
主要终点
Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.

研究概览

简要总结

The primary aim of this study are to gather data on the "real world" experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.

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

  • All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.

排除标准

  • 未提供

结局指标

主要结局

Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.

时间窗: Admission

Proportion of patients with successful revascularization of the occluded target vessel as defined by a TIMI score of 2 or 3 following use of the Penumbra System.

时间窗: Post-Procedure

The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.

时间窗: 90-Days Post-Procedure

次要结局

  • Incidence of intracranial hemorrhage.(24-Hours Post-Procedure)
  • Incidence of device-related serious adverse events.(During the Procedure)
  • All cause mortality at 90 days post-procedure.(90-Days Post-Procedure)
  • Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.(Admission and Discharge)

研究者

发起方
Penumbra Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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