Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Trial ID or NCT#
In this multicenter, international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease. Patients will be randomized to an angiographic strategy, where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve, an index measured with the pressure wire, will be used to determine which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A secondary outcome will be cost-effectiveness.
- - at least 2 coronary lesions of 50% stenosis or greater in at least 2 major epicardial arteries - age>/=18
- -- STEMI < 5 days ago or non-STEMI with CK > 1000 U/l < 5 days ago - Pregnancy - Extremely tortuous or calcified coronary arteries, or other technical conditions interfering with reliable coronary pressure measurement - Serious concomitant disease, decreasing life expectancy to <2 years - Previous coronary bypass surgery (CABG) - Contraindication for drug-eluting stent - Cardiogenic shock - Inability to give informed consent - Suspicion of significant left main (LM) stenosis
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