Flow quantification with ultrasound particle image velocimetry in patients with aortoiliac occlusive disease

Completed

Conditions: peripheral arterial disease
10003216

Registration Number: NL-OMON48975

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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

- 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 < 45 ml/min)
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast media
- Age < 50 (group A)
- Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main predictor variables of this study are flow derived parameters, such<br /><br>as: mean wall shear stress (WSS), oscillatory shear index (OSI), recirculation<br /><br>and blood stasis. Clinical outcome parameters are: lesion severity (duplex US)<br /><br>and ankle-brachial-index (ABI) in group A and primary stent patency in group B<br /><br>and C.</p><br>

Secondary Outcome Measures