Clinical trial NCT04934501: Blood Flow Quantification Near Stented SFA Lesions Using Ultrasound Velocimetry
Official title: Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow Near Stented SFA Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Qualitative assessment vector velocity fields
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
measure: Contrast-to-background ratio
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
measure: Vector correlation
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
Secondary outcomes:
measure: Vorticity
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
measure: Vector complexity
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
measure: Correlation echoPIV and CFD
timeFrame: 6 to 8 weeks after the procedure (stent placement of SFA)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Dept. of Surgery, Rijnstate Hospital Arnhem
name: Michel MPJ Reijnen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.