FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Other: Stenting plus OMT
Other: Standard of care
Other: OMT

Registration Number: NCT01132495

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

Detailed Description: Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1170

Inclusion Criteria

Patients with
- stable angina or,
- stabilized angina pectoris or,
- atypical chest pain or no chest pain but with documented silent ischemia
at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
Eligible for PCI
Signed written informed consent

Exclusion Criteria

Patients in whom the preferred treatment is CABG
Patients with left main coronary artery disease requiring revascularization
Patients with a recent STEMI or Non-STEMI
Prior CABG
Contra-indication to dual antiplatelet therapy
LVEF < 30%
Severe LV hypertrophy
Planned need for concomitant cardiac surgery
Extremely tortuous or calcified coronary arteries precluding FFR measurements
A life expectancy of less than 2 years
Age under 21

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: PCI plus OMT	Stenting plus OMT	PCI plus optimal medical treatment
Cohort B	Standard of care	FFR \> 0.80; treatment according to local practice
Cohort A: OMT alone	OMT	Optimal medical treatment alone

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event Rate (MACE)	24 Month	MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

Secondary Outcome Measures

Name	Time	Method
Overall MACE	3 years	Individual components of the primary end point, cardiac death, and nonurgent revascularization

Trial Locations

Locations (29): VA Palo Alto
🇺🇸
Palo Alto, California, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
Masaryk University and University Hospital Brno
🇨🇿
Brno, Czechia
Na Homolce Hospital
🇨🇿
Praha, Czechia
Hospices Civils de Lyon
🇫🇷
Bron, France
Sodersjukhuset AB
🇸🇪
Stockholm, Sweden
Clinical Center Kragujevac
🇷🇸
Kragujevac, Serbia
Orebro University Hospital
🇸🇪
Orebro, Sweden
Royal Victoria Hospital
🇬🇧
Belfast, United Kingdom
Edinburgh Heart Centre
🇬🇧
Edinburgh, United Kingdom
Golden Jubilee National Hospital
🇬🇧
Glasgow, United Kingdom
Kings College Hospital
🇬🇧
London, United Kingdom
Southampton University Hospitals NHS
🇬🇧
Southampton, United Kingdom
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Hopital du Sacre-Coeur de Montreal
🇨🇦
Montreal, Quebec, Canada
Klinikum der Universitat Munchen
🇩🇪
Munchen, Germany
Tulane University
🇺🇸
New Orleans, Louisiana, United States
OLV Ziekenhuis
🇧🇪
Aalst, Belgium
Centre Hospitalier de l'Universite de Montreal
🇨🇦
Montreal, Quebec, Canada
Heart Center Leipzig
🇩🇪
Leipzig, Germany
Stadtisches Klinikum Munchen
🇩🇪
Munchen, Germany
Isala Klinieken
🇳🇱
Zwolle, Netherlands
Azienda Ospedaliero Universitaria de Ferrara
🇮🇹
Ferrara, Italy
Catharina-Ziekenhuis
🇳🇱
Eindhoven, Netherlands
Gottsegen Hungarian Institute of Cardiology
🇭🇺
Budapest, Hungary
Rigshospitalet University Hospital
🇩🇰
Copenhagen, Denmark
Emory University
🇺🇸
Atlanta, Georgia, United States
Atlanta VA Medical Center
🇺🇸
Decatur, Georgia, United States
Northeast Cardiology Associates
🇺🇸
Bangor, Maine, United States