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 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
Exclusion Criteria:
- 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
Investigator(s)
William Fearon, MD
Interventional cardiologist,
Cardiologist
Professor of Medicine (Cardiovascular Medicine)
Todd Brinton
Jennifer Tremmel
Interventional cardiologist,
Cardiologist
Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)
Contact us to find out if this trial is right for you.
Contact
Maria Perlas
6507232094
View on ClinicalTrials.gov
