To determine the accuracy of computational fluid dynamic models for the quantification of the pressure gradient of tandem stenoses in the femoropopliteal artery, as compared to invasive pressure measurements.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the level of agreement between computational
simulations and the measurements of the pressure gradient over the full lesion,
as assessed by the limits of agreement by a Bland-Altman analysis.
Secondary outcome
Clinical improvement (improvement in Rutherford classification) after
femoropopliteal angioplasty and an exploratory analysis of the predictive power
for clinical response by the pressure gradient.
Background summary
Peripheral arterial disease (PAD) in the lower extremity is the third leading
cause of atherosclerotic cardiovascular morbidity. For isolated stenotic
lesions, the decision to treat can be based on well-documented and
cost-effective anatomic and functional clinical modalities. For two or more
stenotic lesions in proximity (tandem stenoses), no evidence-based,
non-invasive treatment indication is available. Personalized patient models
that rely on Computational Fluid Dynamics (CFD) have a proven track record as
non-invasive treatment indication for coronary artery lesions and could aid
treatment decisions for patients with tandem stenosis in the femoropopliteal
artery.
Study objective
To determine the accuracy of computational fluid dynamic models for the
quantification of the pressure gradient of tandem stenoses in the
femoropopliteal artery, as compared to invasive pressure measurements.
Study design
Single-center, observational study with invasive measurements.
Study burden and risks
The study burden is minimal and is only related to the percutaneous angiography
procedure for which the patients are planned on clinical grounds. During this
procedure, the burden consists of an extension of the procedure by 15 minutes
and minor radiation exposure. Patients possibly receive a benefit from the
study procedure, as the pressure measurements provide additional information on
the lesion severity for the treating physician. The study results contribute to
a potentially optimized treatment for future patients with the same disease.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Written informed consent
Scheduled angiography and/or endovascular treatment for femoropopliteal
stenotic disease
Two or more stenoses in the femoropopliteal artery
Pre-proccedural CT-angiography or MR-angiography of the femoropopliteal
arteries
Exclusion criteria
Known atrial fibrillation with irregular ventricular response rate
Occluded superficial femoral artery or popliteal artery
Women of child-bearing age not on active birth control
Inability to sign informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77052.091.21 |
| OMON | NL-OMON25215 |