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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132495
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 9, 2016
Last Update Posted : February 2, 2017
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Stenting plus OMT Other: OMT Other: Standard of care Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : May 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Cohort A: PCI plus OMT
PCI plus optimal medical treatment
Other: Stenting plus OMT
FFR guided PCI, plus OMT
Cohort A: OMT alone
Optimal medical treatment alone
Other: OMT
OMT alone
Cohort B
FFR > 0.80; treatment according to local practice
Other: Standard of care
FFR > 0.80; treatment according to local practice

Primary Outcome Measures :
  1. Major Adverse Cardiac Event Rate (MACE) [ Time Frame: 24 Month ]
    MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

Secondary Outcome Measures :
  1. Overall MACE [ Time Frame: 5 years ]
    Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132495

  Hide Study Locations
United States, California
VA Palo Alto
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maine
Northeast Cardiology Associates
Bangor, Maine, United States, 04401
OLV Ziekenhuis
Aalst, Belgium, 9300
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W 1T8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Czech Republic
Masaryk University and University Hospital Brno
Brno, Czech Republic, 625 00
Na Homolce Hospital
Praha, Czech Republic, 150 16
Rigshospitalet University Hospital
Copenhagen, Denmark, DK-2100
Hospices Civils de Lyon
Bron, France, 69677
Heart Center Leipzig
Leipzig, Germany, 04289
Klinikum der Universitat Munchen
Munchen, Germany, 80336
Stadtisches Klinikum Munchen
Munchen, Germany, 80337
Gottsegen Hungarian Institute of Cardiology
Budapest, Hungary, 1086
Royal Victoria Hospital
Belfast, Ireland, BT12 6BA
Azienda Ospedaliero Universitaria de Ferrara
Ferrara, Italy, 44100
Eindhoven, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Orebro University Hospital
Orebro, Sweden, 701 85
Sodersjukhuset AB
Stockholm, Sweden, 11883
United Kingdom
Edinburgh Heart Centre
Edinburgh, United Kingdom, EH16 4SA
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4HX
Kings College Hospital
London, United Kingdom, SE5 9RS
Southampton University Hospitals NHS
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Bernard De Bruyne, MD O.L.Vrouwzlekenhuis Hospital

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: St. Jude Medical Identifier: NCT01132495     History of Changes
Other Study ID Numbers: 0904
First Posted: May 28, 2010    Key Record Dates
Results First Posted: December 9, 2016
Last Update Posted: February 2, 2017
Last Verified: December 2016

Keywords provided by St. Jude Medical:
Stable angina
angina pectoris
Fractional Flow Reserve
Pressure wire

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases