Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry (EchoPIV in SFA)
21 de junio de 2021 actualizado por: Rijnstate Hospital
Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
20
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gelderland
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Arnhem, Gelderland, Países Bajos
- Rijnstate Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with peripheral arterial disease who have been treated with a stent placement in the superficial femoral artery.
Descripción
Inclusion Criteria:
- Scheduled endovascular treatment of a lesion in the SFA through placement of a bare metal or a covered stent
- A recently (<6 weeks) treated lesion in the SFA through placement of a bare metal or a covered stent
Exclusion Criteria:
- Hypersensitivity to the active substance(s) or any of the excipients in SonoVue
- Right-to-left cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Adult respiratory distress syndrome
- Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress syndrome)
- Clinically unstable cardiac disease (recent or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrythmia's, endocarditis, etc.)
- Prosthetic valves
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- End-stage liver disease Sepsis
- Hypercoagulable status, recent thrombosis
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast media
- Pregnancy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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PAD patients
The entire cohort exists of patients recently treated with an endovascular stent placement in the superficial femoral artery (SFA).
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Qualitative assessment vector velocity fields
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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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.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Contrast-to-background ratio
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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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.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Vector correlation
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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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.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Vorticity
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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Multiple blood flow parameters will be derived from the echoPIV data.
The first one is the vorticity, or the curl of the velocity.
The vorticity represents the rotation of particles inside the flow field.
This measure can potentially be used to define regions with disturbed blood flow, as a high value (in rad/s) indicates the occurence of a recirculation.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Vector complexity
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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The second blood flow parameters derived from the echoPIV data is the vector complexity.
Vector complexity is a measure of multi-directional flow, ranging from 0 till 1. a value of 1 means complex flow with all velocity vectors pointing in all directions, whereas a value of 0 means laminar flow with all velocity vectors pointing in the same direction.
This measure can potentially be used to indicate regions with disturbed blood flow.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Correlation echoPIV and CFD
Periodo de tiempo: 6 to 8 weeks after the procedure (stent placement of SFA)
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Velocity profiles obtained with echoPIV will be compared to outcomes of a computational fluid dynamics (CFD) simulation model of the femoral artery.
Multiple points along the imaged vessel will be selected in both the echoPIV and the CFD data to extract the temporal velocity profile.
This profile will be compared point-by-point after which the correlation between both outcomes/techniques will be obtained.
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6 to 8 weeks after the procedure (stent placement of SFA)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michel MPJ Reijnen, PhD, Dept. of Surgery, Rijnstate Hospital Arnhem
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de agosto de 2018
Finalización primaria (Actual)
30 de agosto de 2019
Finalización del estudio (Actual)
30 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
21 de junio de 2021
Publicado por primera vez (Actual)
22 de junio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de junio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-1206
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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