peripheral arterial disease
Conditions
Interventions
None listed
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Group A: - Recently diagnosed untreated aortoiliac stenotic lesion, confirmed with Duplex US (>50%) - Presence of claudication symptoms, but no pain at rest (Fontaine 2a / 2b) - Exercise therapy prescribed, Group B: - Recent endovascular treatment of an iliac stenotic lesion through placement of a single stent. Group C: - Recent endovascular treatment of extensive aortoiliac lesion with a CERAB or KS configuration.
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, clinically worsening cardiac symptoms, severe cardiac arrythmia*s, etc.) - Loss of renal function (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main predictor variables of this study are flow derived parameters, such as: mean wall shear stress (WSS), oscillatory shear index (OSI), recirculation and blood stasis. Clinical outcome parameters are: lesion severity (duplex US) and ankle-brachial-index (ABI) in group A and primary stent patency in group B and C. | — |
Countries
Netherlands
Outcome results
None listed