NCT03497637

Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,054 (estimated)
• Sponsor: Helios Health Institute GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Coronary Artery Stenoses

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	measurement of FFR	use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
DIAGNOSTIC_TEST	measurement of Pd/Pa	use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses

Timeline

• Start date: 2020-10-23
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2018-04-13
• Last updated: 2024-11-25

Locations

8 sites across 1 country: Germany