Trial Search Results

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 accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Houston Methodist DeBakey Heart and Vascular Center, Houston

Stanford Investigator(s):

Intervention(s):

  • Procedure: FFR guided PCI
  • Procedure: CABG

Phase:

Phase 4

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
William F Fearon, MD
650-725-2621
Recruiting