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Feasibility of ultrasound particle image velocimetry to quantify flow near stented SFA lesions

Completed
Conditions
''peripheral arterial disease''
10003216
Registration Number
NL-OMON46197
Lead Sponsor
Rijnstate Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
21
Inclusion Criteria

A scheduled treatment or 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 myorcardial infarction, unstable angina at rest, clinically worsening cardiac symptoms, severe cardiac arrythmia*s, etc.)
- Loss of renal function (GFR < 31 ml/min)
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast media
- Pregnancy

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Vector velocity fields derived from the echo PIV data will be used to calculate<br /><br>and visualize the velocity profile. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Vector velocity fields derived from computational fluid dynamics (CFD) data<br /><br>will be used to calculate and visualize the velocity profile and to validate<br /><br>the echo PIV results. Furthermore the wall shear stress (WSS) and the<br /><br>oscillatory shear index (OSI) will be calculated from both the echo PIV as the<br /><br>CFD data. Specific flow patterns, e.g. recirculation or blood stasis, will also<br /><br>be analysed.</p><br>
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