Education and Training
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: FFR guided PCI
- procedure: CABG
- device: Resolute Integrity Stent
- device: Resolute Onyx Stent
Eligibility
Inclusion Criteria:
- 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. 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
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
William F Fearon, MD
650-725-2621
Not Recruiting