vascular diseases - vaatziekten Atherosclerosis - Atherosclerose Peripheral arterial disease - perifeer vaatlijden Aortoiliac Occlusive Disease - Aortoiliacaal occlusief lijden Necrosis - Necrose
Conditions
Interventions
none
Sponsors
Rijnstate Hospital
Wagnerlaan 55
6815 AD Arnhem
Eligibility
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: - Planned endovascular treatment of an iliac stenotic lesion through placement of a single stent. Group C: - Schedul ed endovascular treatment of extensive aortoiliac lesion with a CERAB 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 hyperte nsion (pulmonary artery pressure > 90mmHg) - Uncontrolled systemic hypertension - Severe pulmonary disease (e.g. COP D GOLD 3/4, adult respiratory distress syndrome) - Clinically unstable cardiac disease (recent or ongoing myorcardial infarction, unstable a ngina at rest, clinically worsening cardiac symptoms, severe cardiac arrythmia’s, etc.) - Loss of renal function (GFR < 45 ml/min) - Congestive heart failure (class III or IV) - Hypersensitivity to iodinated contrast m edia - Age < 50 (group A) - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| group A: Lesion severity (duplex) Group B & C: Primary patency | — |
Secondary
| Measure | Time frame |
|---|---|
| Group A: Walking distance, Ankle-Brachial-Index Mortality, Quality of life | — |
Contacts
Public ContactStefan Engelhard
Outcome results
None listed