Feasibility of ultrasound particle image velocimetry to quantify swirling flow inside the flow-modulating Biomimics 3D vascular stent

Completed

• Conditions: 10003216; Peripheral arterial disease

• Registration Number: NL-OMON51308
• Lead Sponsor: niversiteit Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-22
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

- Male or female > 18 years of age
- Stenotic lesion in the SFA treated with a BioMimic 3D stent
- Willingness to visit the hospital and undergo HFR-CEUS measurements and a CTA
scan
- Signed informed consent

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
- Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress
syndrome)
- Clinically unstable cardiac disease (recent or ongoing myorcardial
infarction, unstable angina at rest, recent
percutaneous coronary intervention (PCI), clinically worsening cardiac
symptoms, severe cardiac arrythmia*s,
endocarditis, etc.)
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- Hypersensitivity to iodinated contrast media
- Hypercoagulable status, recent thrombosis
- Congestive heart failure (class III or IV)
- Pregnancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Vector velocity fields derived from echoPIV data will be used to calculate and<br /><br>visualize spatiotemporal blood flow velocity profiles. Offline analysis will be<br /><br>used to investigate the existence of swirling flow patterns. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are as follows:<br /><br>- The spatiotemporal swirling blood flow patterns obtained with echoPIV with<br /><br>the patient in supine position and in sitting position will be compared to<br /><br>investigate the influence of the patients* position on swirling blood flow<br /><br>patterns.<br /><br>- CTA images from the patients* upper leg will be used to assess the geometry<br /><br>of the treated vessel and its link to echoPIV outcomes in terms of swirling<br /><br>flow.<br /><br>- Velocity estimates obtained with conventional Doppler ultrasound will be<br /><br>compared to echoPIV outcomes.<br /><br>- Flow related parameters, indicating the presence of swirling flow, will be<br /><br>calculated. </p><br>