Trial Search Results

Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)

In this multicenter, international study we are evaluating two approaches to determine which coronary artery narrowings require stent placement in patients with multivessel coronary artery disease. Patients will be randomized to an angiographic strategy, where only coronary angiography is used to determine which lesions to stent or to a pressure wire strategy where fractional flow reserve, an index measured with the pressure wire, will be used to determine which lesions to stent. The primary outcome will be major adverse cardiac events at 1 year. A secondary outcome will be cost-effectiveness.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Fractional flow reserve
  • Procedure: Angio-guided PCI

Phase:

N/A

Eligibility


Inclusion Criteria:- at least 2 coronary lesions of 50% stenosis or greater in at least 2
major epicardial arteries

   - age>/=18

Exclusion Criteria:-- STEMI < 5 days ago or non-STEMI with CK > 1000 U/l < 5 days ago

   - Pregnancy

   - Extremely tortuous or calcified coronary arteries, or other technical conditions
   interfering with reliable coronary pressure measurement

   - Serious concomitant disease, decreasing life expectancy to <2 years

   - Previous coronary bypass surgery (CABG)

   - Contraindication for drug-eluting stent

   - Cardiogenic shock

   - Inability to give informed consent

   - Suspicion of significant left main (LM) stenosis

Ages Eligible for Study

18 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 Fearon
6507252621
Not Recruiting