Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry (EchoPIV in SFA)

Rijnstate Hospital

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Diagnostic Test: High-frame-rate contrast-enhanced ultrasound measurements (echoPIV); Diagnostic Test: Computed tomography angiography (CTA) scan

Study type: Observational

Funder types: Other

Identifiers

NCT04934501

2018-1206

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

PAD patients

Description:

The entire cohort exists of patients recently treated with an endovascular stent placement in the superficial femoral artery (SFA).

Treatment:

Diagnostic Test: Computed tomography angiography (CTA) scan

Diagnostic Test: High-frame-rate contrast-enhanced ultrasound measurements (echoPIV)