Trial Search Results

FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

St. Jude Medical

Intervention(s):

  • Other: Stenting plus OMT
  • Other: OMT
  • Other: Standard of care

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   1. Patients with

      - stable angina or,

      - stabilized angina pectoris or,

      - atypical chest pain or no chest pain but with documented silent ischemia

   2. at least one stenosis is present of at least 50% in one major native epicardial
   coronary artery and supplying viable myocardium

   3. Eligible for PCI

   4. Signed written informed consent

Exclusion Criteria:

   1. Patients in whom the preferred treatment is CABG

   2. Patients with left main coronary artery disease requiring revascularization

   3. Patients with a recent STEMI or Non-STEMI

   4. Prior CABG

   5. Contra-indication to dual antiplatelet therapy

   6. LVEF < 30%

   7. Severe LV hypertrophy

   8. Planned need for concomitant cardiac surgery

   9. Extremely tortuous or calcified coronary arteries precluding FFR measurements

10. A life expectancy of less than 2 years

11. Age under 21

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
Maria Perlas
6507232094
Not Recruiting