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

NCT ID: NCT01922609

Last Updated: 2013-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31

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.

Conditions

Carotid Occlusion Intolerance

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal cerebrovascular reserve

Patients without preprocedural TCD signs of impaired cerebrovascular reserve

No interventions assigned to this group

Impaired cerebrovascular reserve

Patients with preprocedural TCD signs of impaired cerebrovascular reserve

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Miloslav Spacek, MD

Miloslav Spacek, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miloslav Spacek, MD

Role: PRINCIPAL_INVESTIGATOR

Department of cardiology, University Hospital Motol

Josef Veselka, MD, PhD

Role: STUDY_CHAIR

Department of cardiology, University Hospital Motol

Locations

Department of Cardiology, University Hospital Motol

Prague, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Facility Contacts

Miloslav Spacek, MD

Role: primary

mildaspacek@gmail.com

0042022443 ext. 4901

Other Identifiers

EK-1075/13

Identifier Type: -

Identifier Source: org_study_id