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

Abbott

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: OMT; Other: Stenting plus OMT; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01132495

0904 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.

Enrollment: 1,170 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,170 participants in 3 patient groups

Cohort A: PCI plus OMT

Other group

Description:

PCI plus optimal medical treatment

Treatment:

Other: Stenting plus OMT

Cohort A: OMT alone

Other group

Description:

Optimal medical treatment alone

Treatment:

Other: OMT

Cohort B

Other group

Description:

FFR \> 0.80; treatment according to local practice

Treatment:

Other: Standard of care