FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Trial ID or NCT#
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
- 1. Patients with - stable angina or, - stabilized angina pectoris or, - atypical chest pain or no chest pain but with documented silent ischemia 2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium 3. Eligible for PCI 4. Signed written informed consent
- 1. Patients in whom the preferred treatment is CABG 2. Patients with left main coronary artery disease requiring revascularization 3. Patients with a recent STEMI or Non-STEMI 4. Prior CABG 5. Contra-indication to dual antiplatelet therapy 6. LVEF < 30% 7. Severe LV hypertrophy 8. Planned need for concomitant cardiac surgery 9. Extremely tortuous or calcified coronary arteries precluding FFR measurements 10. A life expectancy of less than 2 years 11. Age under 21
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