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

Sponsor

University Hospital, Motol (Other)

Overall Status

Unknown status

CT.gov ID

NCT01922609

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Occlusion Intolerance

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Normal cerebrovascular reserve Patients without preprocedural TCD signs of impaired cerebrovascular reserve
Impaired cerebrovascular reserve Patients with preprocedural TCD signs of impaired cerebrovascular reserve

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, University Hospital Motol	Prague		Czech Republic	15006

Sponsors and Collaborators

University Hospital, Motol

Investigators

Principal Investigator: Miloslav Spacek, MD, Department of cardiology, University Hospital Motol
Study Chair: Josef Veselka, MD, PhD, Department of cardiology, University Hospital Motol