FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Trial ID or NCT#
Status
Purpose
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.
Official Title
Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease
Eligibility Criteria
- 1. Patients with
- * stable angina or, * stabilized angina pectoris or, * atypical chest pain or no chest pain but with documented silent ischemia2. at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium3. Eligible for PCI4. Signed written informed consent
- 1. Patients in whom the preferred treatment is CABG2. Patients with left main coronary artery disease requiring revascularization3. Patients with a recent STEMI or Non-STEMI4. Prior CABG5. Contra-indication to dual antiplatelet therapy6. LVEF \< 30%7. Severe LV hypertrophy8. Planned need for concomitant cardiac surgery9. Extremely tortuous or calcified coronary arteries precluding FFR measurements10. A life expectancy of less than 2 years11. Age under 21
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Maria Perlas
6507232094
View on ClinicalTrials.gov