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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01922609

Enrollment

Registered

2013-08-14

Start date

2013-05-31

Completion date

Unknown

Last updated

2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Occlusion Intolerance

Keywords

Carotid stenting, Proximal protection system, Transcranial Doppler ultrasound, Cerebrovascular reserve

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Czechia

Outcome results