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Clinical Trials/NCT01132495
NCT01132495
Completed
Not Applicable

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

Abbott Medical Devices29 sites in 13 countries1,170 target enrollmentMay 2010
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Abbott Medical Devices
Enrollment
1170
Locations
29
Primary Endpoint
Major Adverse Cardiac Event Rate (MACE)
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
May 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • •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

Outcomes

Primary Outcomes

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 Outcomes

  • Overall MACE(3 years)

Study Sites (29)

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