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

• Conditions: Carotid Occlusion Intolerance

• Registration Number: NCT01922609
• Lead Sponsor: University Hospital, Motol

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Status Verified: 2013-08
• Study First Submitted: 2013-08-11
• Study First Submitted QC: 2013-08-11
• Last Update Submitted: 2013-08-11
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carotid occlusion intolerance	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.

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Motol; 🇨🇿 Prague, Czech Republic