Computational Fluid Dynamics for estimating the Pressure Gradient of Serial Stenotic Lesions

Recruiting

• Conditions: Peripheral arterial disease; vessel narrowing; 10003216

• Registration Number: NL-OMON51232
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• 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 invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter is the level of agreement between computational<br /><br>simulations and the measurements of the pressure gradient over the full lesion,<br /><br>as assessed by the limits of agreement by a Bland-Altman analysis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical improvement (improvement in Rutherford classification) after<br /><br>femoropopliteal angioplasty and an exploratory analysis of the predictive power<br /><br>for clinical response by the pressure gradient. </p><br>