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CompletedNCT06170580CAS-iFLOWUpdated Mar 21, 2025

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

An observational study in Carotid Artery Stenosis, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Carotid Artery Stenosis
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 20 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

10 patients with and 10 patients without a hemodynamic significant carotid artery stenosis

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants with a hemodynamic significant carotid artery stenosis

    Diagnostic Test: Conventional duplex · Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging · Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging

  • Participants without a hemodynamic significant carotid artery stenosis

    Diagnostic Test: Conventional duplex · Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging · Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging

Interventions

  • Diagnostic testConventional duplex

    Conventional carotid duplex measurement

  • Diagnostic testUltrasound-based flow imaging using plane wave imaging

    Ultrasound-based flow imaging using plane wave imaging

  • Diagnostic testUltrasound-based flow imaging using cascaded wave imaging

    Ultrasound-based flow imaging using cascaded wave imaging

06

What researchers measure

Primary outcomes

  1. 2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery

    Time frame: After study completion, average of one year

Secondary outcomes

  1. Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths

    Time frame: After study completion, average of one year

  2. Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths

    Time frame: After study completion, average of one year

  3. Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared

    Time frame: After study completion, average of one year

  4. Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.

    Time frame: After study completion, average of one year

  5. Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques

    Time frame: After study completion, average of one year

07

Study locations

1 site
  • Radboud university medical center
    Nijmegen, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06170580
Lead sponsor
Radboud University Medical Center
Collaborators
Netherlands Organisation for Scientific Research
Responsible party
Sponsor
First posted
Dec 14, 2023
Start date
Nov 16, 2023
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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