PreSet study
- Conditions
- Peripheral Artery Disease
- Registration Number
- NL-OMON25215
- Lead Sponsor
- Rijnstate
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.