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

Trial ID or NCT#

NCT02100722

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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
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Investigator(s)

William Fearon, MD
William Fearon, MD
Interventional cardiologist, Cardiologist
Professor of Medicine (Cardiovascular Medicine)
Celina Yong, MD, MBA, MSc

Contact us to find out if this trial is right for you.

Contact

William F Fearon, MD
650-725-2621

View on ClinicalTrials.gov