Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.
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
- 否
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
Miloslav Spacek, MD
Miloslav Spacek, MD
University Hospital, Motol
