NCT04318171

Brief Summary

This study concentrates on providing more ultrasound image details when scanning vascular system including arterial and venous systems. A new sensor which provides 3D images is newly designed. It will be used in this study to find out whether it can change the future of vascular imaging or not.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

March 16, 2020

Last Update Submit

January 20, 2023

Conditions

Carotid Artery Plaque

Outcome Measures

Primary Outcomes (3)

  • Peck systolic velocity

    Normal peck systolic velocity (PSV) is 125cm/s. More than 250 cm/s considered 50% stenosis .

    12 weeks

  • Peck systolic ration

    Normal peak systolic velocity rations less than 1.5 and more than 2 is considered 50% stenosis. This can be calculated by measuring the peak systolic velocity within the stenotic area divided by either pre or post stenotic area.

    12 weeks

  • Diameter reduction measurement

    The ultrasound medicine does calculate the diameter reduction automatically when the operator places the calliper at the vessels wall.

    12 weeks

Secondary Outcomes (5)

  • Plaque volume

    12 weeks

  • Max area stenosis.

    12 weeks

  • Volumetric stenosis.

    12 weeks

  • Measured length.

    12 weeks

  • 3D GSM.

    12 weeks

Study Arms (4)

Carotid arteries.

No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards.

Device: 3D Imaging.

Peripheral arteries.

No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards.

Device: 3D Imaging.

AVF.

No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards.

Device: 3D Imaging.

Vein mapping

No intervention is required. Routine Doppler assessment + 3D scan immediately afterwards.

Device: 3D Imaging.

Interventions

3D Imaging.DEVICE

When the normal Doppler assessment is done following nationally approved protocol for scanning Carotid arteries, lower and upper limb arteries, AVF and Vein mapping. PIUR tUS infinity system 3D Bluetooth motion sensor which is linked to video transmission box will be used to scan the patient's common carotid artery (CCA), internal carotid artery (ICA) and external carotid artery (ECA) in transverse view to obtain the following measurements: * Plaque volume where detectable. * Max area stenosis. * Volumetric stenosis. * Measured length. * 3D GSM. The entire assessment should not take more than 45 minutes.

AVF.Carotid arteries.Peripheral arteries.Vein mapping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients selected for this study must have arterial stenosis.

You may qualify if:

  • ≥ 18 years age with vascular disease.
  • Male / Female.

You may not qualify if:

  • \<18 years age.
  • Patient with congenital vascular abnormalities/syndromes.
  • Pregnant patients will not be recruited in this study. Patient's pregnancy status will be assessed on initial enrollment to exclude them from the study.
  • Those unable to provide consent.
  • Anyone who is taking part in any other research.
  • Potential participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W120HS, United Kingdom

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 23, 2020

Study Start

July 1, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)