Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation

Design: Patients with one or more coronary stenoses, in which the physiological severity from coronary angiography is in question, will be randomised 1:1 to use of the instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) to guide the treatment strategy for percutaneous coronary intervention (PCI). Aims: To assess whether the iFR is non-inferior to FFR when used to guide treatment of coronary stenosis with PCI. Outcome measures: The primary endpoint will be major adverse cardiac event rate in the iFR and FFR groups at 30 days, 1, 2, and 5 years. Population: This will be an international multi-centre study of 2500 patients. From population estimates, 35% of the total study population will present with stable angina and 65% will have acute coronary syndrome. Eligibility: Patients will be eligible when the physiological severity of a stenosis within a vessel is in question. In the cases of stable angina this will be confined to the target vessel, or with acute coronary syndrome assessment this will be made in the non-culprit vessel. Duration: Anticipated recruitment is 12 months. Follow-up will be performed at 30 days, 1, 2 and 5 years. Results: Primary outcome results will be reported in Spring 2017.