Fractional Flow Reserve-Guided Percutaneous Coronary Intervention plus Optimal Medical Treatment versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease

Phase 4

Completed

Conditions: coronary artery disease
coronary artery narrowings
10011082

Registration Number: NL-OMON38089

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Stable coronary artery disease
At least one coronary stenosis of at least 50% diameter stenosis
Eligible for PCI
Signed written informed consent

Exclusion Criteria

Preferred treatment is CABG
Left main disease requiring revascularization
STEMI or NSTEMI < 1 week
Prior CABG
LVEF<30%
Extremely tortueus or clacified vessels
Requiring concomitant cardiac surgery
Pregnancy or intention to become pregnant during the trial
Life expectancy less than 2 years
Participation in another trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end-point of the FAME II study is the 24-month major adverse<br /><br>cardiac event rate (MACE) defined as:<br /><br><br /><br>• All cause death<br /><br>• Documented myocardial infarction<br /><br>• Unplanned hospitalization leading to urgent revascularization<br /><br><br /><br>as adjudicated by the Critical Event Committee (CEC). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary end-points of the FAME II study include the following:<br /><br><br /><br>• Overall MACE and each individual components of MACE and their combination at<br /><br>each point in time (after 1, 6, 12 month and 1, 3, and 5 years of follow-up).<br /><br>• Non-urgent revascularization procedures<br /><br>• Cost and cost-effectiveness at each point in time.<br /><br>• Functional class at each point in time (including freedom from angina)<br /><br>• Number of anti-anginal medication at each point in time.<br /><br>• Rate of non-urgent (repeat) revascularization at each point in time.<br /><br>• Rate of any cerebrovascular event at each point in time.<br /><br><br /><br>as adjudicated by the Critical Event Committee (CEC).</p><br>