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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38089

Enrollment

300

Registered

2010-06-22

Start date

2010-07-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease coronary artery narrowings

Interventions

Whatever the allocated intervention, all the indicated lesions will be assessed using FFR. When the patient is randomized to optimal medical therapy (OMT) alone, all lesions will be measured but non

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Preferred treatment is CABG Left main disease requiring revascularization STEMI or NSTEMI

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)