Peripheral Artery Disease
Conditions
Interventions
Pressurewire measurement after intra-arterial injection of a vasodilator
Sponsors
Rijnstate
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactLennart van de Velde
Rijnstate, department of vascular surgery
Outcome results
None listed