NCT02100722Completed
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1500 (actual)
- First submitted
- 21 Mar 2014
- Start date
- 25 Aug 2014
- Primary completion date
- 1 Dec 2020
- Lead sponsor
- Stanford University
- Diseases
- Coronary artery disease
- NCT number
- NCT02100722
What you commit to
- Study type: Interventional
- Participants enrolled: 1500
- From 25 Aug 2014 to the primary completion date, 1 Dec 2020
- 46 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Recent STEMI (\<5 days prior to randomization)
- 7\. Requiring renal replacement therapy
- 8\. Undergoing evaluation for organ transplantation
- 11\. Inability to take dual antiplatelet therapy for six months
- 12\. Previous CABG
- 15\. Any target lesion with in-stent drug-eluting stent restenosis
Other illness
- 1\. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization)
- 4\. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
- 13\. Left main disease requiring revascularization
Lab values
- 5\. Known left ventricular ejection fraction \<30%
Age
- 6\. Life expectancy \< 2 years
Other
- 2\. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- 9\. Participation or planned participation in another clinical trial, except for observational registries
- 10\. Pregnancy
- 14\. Extremely calcified or tortuous vessels precluding FFR measurement
Who the study is looking for
- 1\. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
- 2\. Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have ≥50% stenosis
- 3\. Willing and able to provide informed, written consent
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peninsula Health Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal North Shore Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| University of Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Concord Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Cardiovascular Center Aalst Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| Le Centre Hospitalier de l'Université de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| York PCI Group INC Coordinator of this site? Confirm its status | Ontario | Canada | Unknown status |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Masaryk University and University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Rigshospitalet University Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Cardiovascular Hospital Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Wales Heart Research Institute Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| University Hospitals Coventry and Warwickshire Coordinator of this site? Confirm its status | Coventry and Warwickshire | United Kingdom | Unknown status |
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St Thomas Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Oxford University Hospital NHS Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Southampton University Hospitals NHS Trust Coordinator of this site? Confirm its status | Southhampton | United Kingdom | Unknown status |
| Hungarian Institute of Cardiology Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Vilnius University Hospital Santariškių Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Catharina Hospital Eindhoven Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| HagaZiekenhuis Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Isala Klinieken Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| Waikato Hospital Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| University Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Center Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Karolinska Institutet, Dep of clinical science and education, Södersjukhuset Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Danderyds sjukhus Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Jesse Brown VA Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Atlanta VA Medical Center Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Lawrence | United States | Unknown status |
| University of Kentucky Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Lexinton VA Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Centennial Heart Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Palo Alto VA Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Penn Presbyterian Medical Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| HealthEast St. Joseph's Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
| Baystate Medical Center Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.