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

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ClinicalTrials.gov Identifier: NCT01132495
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : December 9, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: Stenting plus OMT Other: OMT Other: Standard of care Not Applicable

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

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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


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: 3 years ]
    Individual components of the primary end point, cardiac death, and nonurgent revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01132495


  Show 29 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Bernard De Bruyne, MD O.L.Vrouwzlekenhuis Hospital

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

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov 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: September 16, 2019
Last Verified: August 2019
Keywords provided by Abbott Medical Devices:
Stable angina
angina pectoris
PCI
FAME
FAME II
FFR
Fractional Flow Reserve
Pressure wire
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases