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

Study Overview
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Brief Summary
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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
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Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Stenting plus OMT
* Other: OMT
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Event Rate (MACE) | 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 | Individual components of the primary end point, cardiac death, and nonurgent revascularization | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable angina, angina pectoris, PCI, FAME, FAME II, FFR, Fractional Flow Reserve, Pressure wire