Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses — LIPSIASTRATEGY  

Coronary Artery Disease Clinical Trial

Official title: Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses

Status Recruiting

Clinical Trial Summary

This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.

Clinical Trial Description

Coronary angiography is insensitive to assess the physiologic significance of a coronary stenosis. Therefore, clinical guidelines support the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenosis. Nevertheless, the penetration of FFR in clinical routine continues to be limited by its requirement for pharmacological vasodilation, prolonged procedure time and adverse systemic effects from adenosine.

Vessel-FFR (vFFR) is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. The vFFR values at each point along the vessel are color-coded and superimposed on the 3D epicardial model and cut-off values of ≤0.80 identical to standard invasive FFR apply.

These developments may translate towards more physiology guided intervention bearing the potential to improve clinical outcomes in patients with stable CAD. The ability to derive FFR values from routinely performed coronary angiograms, without the practical drawbacks that limit invasive techniques, could have an important impact on daily clinical practice.

To date no randomized outcome-based clinical trial has compared an image-based FFR methodology with standard invasive FFR in terms of subsequent clinical outcomes. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenoses
• Coronary Stenosis

• NCT number: NCT03497637
• Study type: Interventional
• Source: Helios Health Institute GmbH
• Contact: Holger Thiele, MD
• Phone: +49 341 865 1428
• Email: holger.thiele@medizin.uni-leipzig.de
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2020
• Completion date: November 1, 2026