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FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Not Recruiting
Trial ID: NCT01132495
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
Stanford Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
Alan Yeung, MD
Li Ka Shing Professor in Cardiology
Jennifer Tremmel
Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)
Eligibility
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
Intervention(s):
other: Stenting plus OMT
other: Standard of care
other: OMT
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Perlas
6507232094