NCT04934501|CompletedDMC
Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry
EchoPIV in SFA
Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
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EchoPIV in SFA
Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
Sponsor study identifier
observational
20
1 country
1
Study Start
August 8, 2018
Actual (reported)Primary Completion
August 30, 2019
Actual (reported)Study Completion
August 30, 2019
Actual (reported)Peripheral arterial disease (PAD) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. Endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. Stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. Visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. Blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. In vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. This study will therefore aim to investigate the feasibility of a novel ultrasound technique (echoPIV) to quantify spatiotemporal blood flow near stented femoral artery lesions. Furthermore, the blood flow information obtained during the echoPIV measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (CFD) simulation. The tested hypothesis is that blood flow quantification using echoPIV is feasible in and around stents in the femoral artery and that it will improve CFD simulations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2018
Actual (reported)August 30, 2019
Actual (reported)August 30, 2019
Actual (reported)June 10, 2021
Actual (reported)June 22, 2021
Actual (reported)Qualitative assessment vector velocity fields
Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.
6 to 8 weeks after the procedure (stent placement of SFA)
Contrast-to-background ratio
The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.
6 to 8 weeks after the procedure (stent placement of SFA)
Vector correlation
The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.
6 to 8 weeks after the procedure (stent placement of SFA)
Vorticity
6 to 8 weeks after the procedure (stent placement of SFA)
Vector complexity
6 to 8 weeks after the procedure (stent placement of SFA)
Correlation echoPIV and CFD
6 to 8 weeks after the procedure (stent placement of SFA)
The entire cohort exists of patients recently treated with an endovascular stent placement in the superficial femoral artery (SFA).
Patients will undergo high-frame-rate contrast-enhanced ultrasound measurements, within 6 to 8 weeks after the endovascular procedure, at the vascular center of Rijnstate hospital. Prior to these measurements a venous cannula will be placed to ensure venous access for the contrast administration.
Patients will undergo a CTA scan of the lower extremities at the Radiology dept. of Rijnstate hospital the same day as the echoPIV measurements. This CTA scan serves as a reference for the vessel geometry and stent location.
Patients with peripheral arterial disease who have been treated with a stent placement in the superficial femoral artery.
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
van Helvert M, Engelhard S, Voorneveld J, van der Vee M, Bosch JG, Versluis M, Groot Jebbink E, Reijnen MMPJ. High-frame-rate contrast-enhanced ultrasound particle image velocimetry in patients with a stented superficial femoral artery: a feasibility study. Eur Radiol Exp. 2022 Jul 6;6(1):32. doi: 10.1186/s41747-022-00278-w.
Michel MPJ Reijnen, PhD
Dept. of Surgery, Rijnstate Hospital Arnhem
20 participants (actual enrollment reported by the registry).
First Submitted
June 10, 2021
First Posted
June 22, 2021
Study Start
August 8, 2018
Actual (reported)Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis
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Primary Completion
August 30, 2019
Actual (reported)Study Completion
August 30, 2019
Actual (reported)Last Updated
June 22, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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