NCT04934501

Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry

Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	High-frame-rate contrast-enhanced ultrasound measurements (echoPIV)	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.
DIAGNOSTIC_TEST	Computed tomography angiography (CTA) scan	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.

Timeline

• Start date: 2018-08-08
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2021-06-22
• Last updated: 2021-06-22

Locations

1 site across 1 country: Netherlands