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

August 8, 2019 updated by: Abbott Medical Devices

Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Study Type

Interventional

Enrollment (Actual)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall MACE
Time Frame: 3 years
Individual components of the primary end point, cardiac death, and nonurgent revascularization
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Bernard De Bruyne, MD, O.L.Vrouwzlekenhuis Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (ESTIMATE)

May 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0904 (Other Grant/Funding Number: Landsteiner Foundation for Blood Transfusion Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Stenting plus OMT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe