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ID
Source
Brief title
Health condition
Peripheral Artery Disease
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. The pressure gradient is measured during the endovascular procedure with a pressure wire, before angioplasty of the lesions.
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. The clinical improvement is measured at 2 months using the Rutherford classification after the endovascular intervention.
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. The study will assess 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 objective
The pressure gradient of tandem stenoses in the femoropopliteal artery computed by computational fluid dynamics has an intra-class correlation coefficient of 0.8 or higher
Study design
1
Intervention
Pressurewire measurement after intra-arterial injection of a vasodilator
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9744 |
| CCMO | NL77052.091.21 |
| OMON | NL-OMON51232 |