A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

Completed · Not applicable

Conditions studied: Coronary Disease, Coronary Stenosis

In brief

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).

Key facts

Study ID

NCT02100722

Run by

Stanford University

People needed

1500

Starts

2014-08-25

Expected to finish

2024-12-01

Last updated by the study team

2026-04-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 1. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization)
• 2. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
• 3. Recent STEMI (<5 days prior to randomization)
• 4. Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
• 5. Known left ventricular ejection fraction <30%
• 6. Life expectancy < 2 years
• 7. Requiring renal replacement therapy
• 8. Undergoing evaluation for organ transplantation
• 9. Participation or planned participation in another clinical trial, except for observational registries
• 10. Pregnancy
• 11. Inability to take dual antiplatelet therapy for six months
• 12. Previous CABG
• 13. Left main disease requiring revascularization
• 14. Extremely calcified or tortuous vessels precluding FFR measurement
• 15. Any target lesion with in-stent drug-eluting stent restenosis

Where it is running

• Palo Alto VA — Palo Alto, California, United States
• Stanford University — Stanford, California, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Jesse Brown VA Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Lawrence, Kansas, United States
• Lexinton VA — Lexington, Kentucky, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Centennial Heart — Nashville, Tennessee, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Peninsula Health — Frankston, Australia
• St. Vincent's Hospital Melbourne — Melbourne, Australia
• Concord Hospital — Sydney, Australia
• Royal North Shore — Sydney, Australia
• University of Sydney — Sydney, Australia
• Cardiovascular Center Aalst — Aalst, Belgium
• Le'Centre Hospitalier de l'Universite de Montreal — Montreal, Canada
• York PCI Group INC — Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Canada
• Masaryk University and University Hospital Brno — Brno, Czechia
• Rigshospitalet University Hospital — Copenhagen, Denmark
• Cardiovascular Hospital — Lyon, France

Full record on ClinicalTrials.gov

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