To identify local flow patterns that can predict disease progression and failure of stent patency in patients with untreated and treated atherosclerotic lesions in the aortoiliac tract.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Visualization of local blood flow patterns in the aortoiliac tract is
challenging, but clinically relevant as specific flow perturbations could
affect atherosclerotic disease progression and stent patency.
Study objective
To identify local flow patterns that can predict disease progression and
failure of stent patency in patients with untreated and treated atherosclerotic
lesions in the aortoiliac tract.
Study design
Prospective cohort study. Subjects will receive ultrasound particle image
velocimetry (echoPIV) measurements at baseline to obtain blood flow velocity
data and to calculate flow derived parameters. 2 year follow-up of subjects
will be performed to measure clinical outcome parameters and the influence of
the calculated flow parameters on these outcome parameters will be
investigated.
Study burden and risks
The burden of this study consists of several extra visits to the hospital
during follow-up, including additional duplex ultrasound (US) examinations and
ABI measurements that are not part of standard care (in group A). CT
angiography scans are performed at baseline, that are not part of standard care
in group A and for some patients in group B. There is a risk of unexpected
findings due to this CTA scan.
For the echoPIV measurements at baseline, a research US machine is used that is
not approved for clinical use. This machine was thoroughly tested and is judged
to be safe for use in humans. Also, an ultrasound contrast agent (UCA) is
injected through a venous cannula during the echoPIV measurements. There is a
very small risk of adverse events associated with the use of this UCA.
Appropriate safety measures have been taken to account for this.
Wagnerlaan 55
Arnhem 6815 AG
NL
Wagnerlaan 55
Arnhem 6815 AG
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63077.091.17 |