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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01132495
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2014-01
• Study Completion: 2015-05
• Results First Submitted: 2016-06-08
• Results First Submitted QC: 2016-10-13
• Results First Posted: 2016-12-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event Rate (MACE)	24 Month	MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

Secondary Outcome Measures

Name	Time	Method
Overall MACE	3 years	Individual components of the primary end point, cardiac death, and nonurgent revascularization

Trial Locations

Locations (29)

VA Palo Alto; 🇺🇸 Palo Alto, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Northeast Cardiology Associates; 🇺🇸 Bangor, Maine, United States

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada

Masaryk University and University Hospital Brno; 🇨🇿 Brno, Czechia

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