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

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01132495

Run by

Abbott Medical Devices

People needed

1170

Starts

2010-05-01

Expected to finish

2015-05-01

Last updated by the study team

2019-09-16

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Na Homolce Hospital — Prague, Czechia
• Rigshospitalet University Hospital — Copenhagen, Denmark
• Hospices Civils de Lyon — Bron, France
• Heart Center Leipzig — Leipzig, Germany
• Klinikum der Universitat Munchen — München, Germany
• Stadtisches Klinikum Munchen — München, Germany
• Gottsegen Hungarian Institute of Cardiology — Budapest, Hungary
• Azienda Ospedaliero Universitaria de Ferrara — Ferrara, Italy
• Catharina-Ziekenhuis — Eindhoven, Netherlands
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands
• Isala Klinieken — Zwolle, Netherlands
• Clinical Center Kragujevac — Kragujevac, Serbia
• Orebro University Hospital — Örebro, Sweden
• Sodersjukhuset AB — Stockholm, Sweden
• Royal Victoria Hospital — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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