跳至主要内容
临床试验/NCT01922609
NCT01922609Unknown不适用

Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.

University Hospital, Motol1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Carotid occlusion intolerance

研究概览

简要总结

The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.

详细描述

Carotid artery stenting procedures are increasingly performed with devices that involve endovascular clamping of the common carotid artery, thus exposing the ipsilateral hemisphere to hypoperfusion. Approximately 5% of patients do not tolerate the clamp and are in increased risk of periprocedural cerebrovascular complication such as transient ischemic attack or stroke. To date, there is no method available that could be used to predict the risk of occlusion intolerance. The aim of this study is to determine whether preprocedural evaluation with transcranial Doppler ultrasonography can be effective in prediction of occlusion intolerance.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Either >50% symptomatic carotid artery stenosis (transient ischemic attack or ischemic stroke within 6 months before procedure) or >70% asymptomatic carotid artery stenosis eligible for carotid artery stenting with proximal flow arrest protection
  • Signed informed consent

排除标准

  • Disagreement to be included in the study
  • Inadequate acoustic window for transcranial Doppler ultrasound monitoring
  • Carotid occlusion
  • Significant extracranial artery stenosis (>50%) other than target artery
  • Inability to hold breath for sufficient time (approximately 30s)

结局指标

主要结局

Carotid occlusion intolerance

时间窗: During carotid stenting procedure

Intolerance of carotid occlusion during carotid artery stenting detected by means of transcranial Doppler evaluation or by clinical signs of occlusion intolerance.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miloslav Spacek, MD

Miloslav Spacek, MD

University Hospital, Motol

研究点 (1)

Loading locations...

相似试验