Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses (LIPSIASTRATEGY)

  • STATUS
    Recruiting
  • End date
    Nov 1, 2026
  • participants needed
    1926
  • sponsor
    Leipzig Heart Institute GmbH
Updated on 30 April 2022
angiography
stenosis
myocardial infarction
angina pectoris
stemi
coronary artery stenosis
stable angina
acute coronary syndrome
arterial disease

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.

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.

Details
Condition Coronary Artery Disease, Coronary Artery Stenoses
Treatment measurement of FFR, measurement of Pd/Pa
Clinical Study IdentifierNCT03497637
SponsorLeipzig Heart Institute GmbH
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18 years
Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
Eligible for coronary angiography and/or PCI
Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis)
Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
Participation in another interventional study

Exclusion Criteria

Previous CABG with patent grafts to the interrogated vessel
Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis)
Total coronary occlusions
Hemodynamic instability (Killip class III-IV)
Heavily calcified or tortuous vessels
Terminal disease with life expectancy of less than 12 months
STEMI within 48 hours of procedure
Severe valvular heart disease
ACS patients with difficulty in assessing which the culprit lesion is
Significant contraindication to adenosine administration (e.g. Asthma bronchiale)
Pregnancy
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