Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Qualitative assessment vector velocity fields
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Qualitative assessment vector velocity fields
时间窗: 6 to 8 weeks after the procedure (stent placement of SFA)
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.
Contrast-to-background ratio
时间窗: 6 to 8 weeks after the procedure (stent placement of SFA)
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.
Vector correlation
时间窗: 6 to 8 weeks after the procedure (stent placement of SFA)
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.
次要结局
- 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))