MedDataX Logo

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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Occlusion Intolerance

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Carotid stenting Proximal protection system Transcranial Doppler ultrasound Cerebrovascular reserve

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miloslav Spacek, MD

Miloslav Spacek, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cardiology, University Hospital Motol

Prague, Czech Republic, Czechia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Miloslav Spacek, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK-1075/13

Identifier Type: -

Identifier Source: org_study_id