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Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (F.A.M.E.)
Not Recruiting
Trial ID: NCT00267774
Purpose
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 Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
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
Intervention(s):
device: Fractional flow reserve
procedure: Angio-guided PCI
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
William Fearon
6507252621