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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
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

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peninsula Health
Coordinator of this site? Confirm its status
FrankstonAustraliaUnknown status
St Vincent's Hospital Melbourne
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MelbourneAustraliaUnknown status
Royal North Shore
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SydneyAustraliaUnknown status
University of Sydney
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SydneyAustraliaUnknown status
Concord Hospital
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SydneyAustraliaUnknown status
Cardiovascular Center Aalst
Coordinator of this site? Confirm its status
AalstBelgiumUnknown status
Le Centre Hospitalier de l'Université de Montreal
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
York PCI Group INC
Coordinator of this site? Confirm its status
OntarioCanadaUnknown status
University of Ottawa Heart Institute
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OttawaCanadaUnknown status
Masaryk University and University Hospital Brno
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BrnoCzechiaUnknown status
Rigshospitalet University Hospital
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CopenhagenDenmarkUnknown status
Cardiovascular Hospital
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LyonFranceUnknown status
Wales Heart Research Institute
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CardiffUnited KingdomUnknown status
University Hospitals Coventry and Warwickshire
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Coventry and WarwickshireUnited KingdomUnknown status
Golden Jubilee National Hospital
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GlasgowUnited KingdomUnknown status
St Thomas Hospital
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Wythenshawe Hospital
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ManchesterUnited KingdomUnknown status
Oxford University Hospital NHS Trust
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OxfordUnited KingdomUnknown status
Southampton University Hospitals NHS Trust
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SouthhamptonUnited KingdomUnknown status
Hungarian Institute of Cardiology
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BudapestHungaryUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Vilnius University Hospital Santariškių Klinikos
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VilniusLithuaniaUnknown status
Catharina Hospital Eindhoven
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EindhovenNetherlandsUnknown status
HagaZiekenhuis
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The HagueNetherlandsUnknown status
Isala Klinieken
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ZwolleNetherlandsUnknown status
Stavanger University Hospital
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StavangerNorwayUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
University Clinical Center of Serbia
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BelgradeSerbiaUnknown status
Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Karolinska Institutet, Dep of clinical science and education, Södersjukhuset
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StockholmSwedenUnknown status
Danderyds sjukhus
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StockholmSwedenUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Jesse Brown VA Medical Center
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ChicagoUnited StatesUnknown status
Atlanta VA Medical Center
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DecaturUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
University of Kansas Medical Center
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LawrenceUnited StatesUnknown status
University of Kentucky Medical Center
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LexingtonUnited StatesUnknown status
Lexinton VA
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LexingtonUnited StatesUnknown status
Centennial Heart
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NashvilleUnited StatesUnknown status
Palo Alto VA
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Palo AltoUnited StatesUnknown status
Penn Presbyterian Medical Center
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PhiladelphiaUnited StatesUnknown status
HealthEast St. Joseph's Hospital
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Saint PaulUnited StatesUnknown status
Baystate Medical Center
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SpringfieldUnited StatesUnknown status
Stanford University
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StanfordUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.