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

Carotid Occlusion Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01922609
• Other study ID #: EK-1075/13
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2013
• Last updated: August 11, 2013
• Start date: May 2013

Study information

• Verified date: August 2013
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carotid Occlusion Intolerance

Locations

Country	Name	City	State
Czech Republic	Department of Cardiology, University Hospital Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No