Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging

NCT ID: NCT06170580

Last Updated: 2025-03-21

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2025-03-10

Brief Summary

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

Objective: To evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis.

Study design: Observational, feasibility study in a total of 10 patients with and 10 patients without a hemodynamic significant carotid artery plaque.

Intervention (observational): all participants will undergo a carotid ultrasound measurement including conventional duplex ultrasound and ultrasound based flow imaging using plane waves and cascaded waves.

Detailed Description

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

Conditions

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

Carotid Artery Stenosis

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

Participants with a hemodynamic significant carotid artery stenosis

Conventional duplex

Intervention Type DIAGNOSTIC_TEST

Conventional carotid duplex measurement

Ultrasound-based flow imaging using plane wave imaging

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using plane wave imaging

Ultrasound-based flow imaging using cascaded wave imaging

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using cascaded wave imaging

Participants without a hemodynamic significant carotid artery stenosis

Conventional duplex

Intervention Type DIAGNOSTIC_TEST

Conventional carotid duplex measurement

Ultrasound-based flow imaging using plane wave imaging

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using plane wave imaging

Ultrasound-based flow imaging using cascaded wave imaging

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using cascaded wave imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional duplex

Conventional carotid duplex measurement

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using plane wave imaging

Ultrasound-based flow imaging using plane wave imaging

Intervention Type DIAGNOSTIC_TEST

Ultrasound-based flow imaging using cascaded wave imaging

Ultrasound-based flow imaging using cascaded wave imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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

Inclusion Criteria

* Capacitated adult male or female (≥18 years old);
* Informed consent form understood and signed;
* Recent conventional duplex measurement of the carotid artery confirming either the absence or presence of a plaque

Exclusion Criteria

* Hampered carotid blood flow imaging during conventional duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
* History of radiation at the head-neck area;
* Participating in another clinical study, interfering on outcomes.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Netherlands Organisation for Scientific Research

OTHER_GOV

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

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

Radboud university medical center

Nijmegen, , Netherlands

Site Status

Countries

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

Netherlands

Other Identifiers

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

114554

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Carotid Ultrasound Study
NCT02001350 COMPLETED
VALVOSOFT® Pivotal Study
NCT05235568 COMPLETED NA