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.
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,170
FFR guided PCI, plus OMT
OMT alone
FFR \> 0.80; treatment according to local practice
Major Adverse Cardiac Event Rate (MACE)
MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.
Time frame: 24 Month
Overall MACE
Individual components of the primary end point, cardiac death, and nonurgent revascularization
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VA Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Tulane University
New Orleans, Louisiana, United States
Northeast Cardiology Associates
Bangor, Maine, United States
OLV Ziekenhuis
Aalst, Belgium
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Masaryk University and University Hospital Brno
Brno, Czechia
...and 19 more locations