Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

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.

Eligibility

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

Conditions3

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