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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carotid Occlusion Intolerance

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal cerebrovascular reserve<br>Patients without preprocedural TCD signs of impaired cerebrovascular reserve | |
| Impaired cerebrovascular reserve<br>Patients with preprocedural TCD signs of impaired cerebrovascular reserve | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid occlusion intolerance | Intolerance of carotid occlusion during carotid artery stenting detected by means of transcranial Doppler evaluation or by clinical signs of occlusion intolerance. | During carotid stenting procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid stenting, Proximal protection system, Transcranial Doppler ultrasound, Cerebrovascular reserve