Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry

NCT04934501 | Completed DMC

• 1 other identifier: 2018-1206
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• 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)

Study Arms (1)

PAD patients

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

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

Interventions

High-frame-rate contrast-enhanced ultrasound measurements (echoPIV) DIAGNOSTIC_TEST

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.

PAD patients

Computed tomography angiography (CTA) scan DIAGNOSTIC_TEST

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.

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral arterial disease who have been treated with a stent placement in the superficial femoral artery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35790584 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Computed Tomography Angiography; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Michel MPJ Reijnen, PhD

  Dept. of Surgery, Rijnstate Hospital Arnhem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 22, 2021
• Study Start: August 8, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

NL (1)