For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 1. Age ≥ 21 years with angina and/or evidence of myocardial ischemia
  2. 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. 3. Willing and able to provide informed, written consent

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Coronary Disease,Coronary Stenosis

Age (in years)

21+

Phase

Not Applicable

Participants needed

1500

Est. Completion Date

Dec 31, 2024

Treatment type

Interventional


Sponsor

Stanford University

ClinicalTrials.gov identifier

NCT02100722

Study number

FAME 3

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