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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51308
Enrollment
5
Registered
2022-03-29
Start date
2023-02-06
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease

Interventions

None listed

Sponsors

Universiteit Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Vector velocity fields derived from echoPIV data will be used to calculate and visualize spatiotemporal blood flow velocity profiles. Offline analysis will be used to investigate the existence of swirling flow patterns.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)