FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Trial ID or NCT#
NCT01132495
Status
NOT RECRUITING
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
Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion 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
Exclusion Criteria:
- 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)
William Fearon, MD
Interventional cardiologist,
Cardiologist
Professor of Medicine (Cardiovascular Medicine)
Jennifer Tremmel
Interventional cardiologist,
Cardiologist
Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)
Todd Brinton
Contact us to find out if this trial is right for you.
Contact
Maria Perlas
6507232094
View on ClinicalTrials.gov
