Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry

NCT ID: NCT04934501

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2019-08-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PAD patients

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

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

Intervention Type: 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.

Computed tomography angiography (CTA) scan

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel MPJ Reijnen, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Surgery, Rijnstate Hospital Arnhem

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 35790584 (View on PubMed)

Other Identifiers

2018-1206

Identifier Type: -

Identifier Source: org_study_id