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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00267774
Recruitment Status : Completed
First Posted : December 21, 2005
Results First Posted : July 27, 2016
Last Update Posted : November 13, 2017
Information provided by (Responsible Party):
William Fearon, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Device: Fractional flow reserve Procedure: Angio-guided PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: FFR guided PCI Device: Fractional flow reserve
Active Comparator: Angio-guided PCI Procedure: Angio-guided PCI

Primary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 1 year ]
    All cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee

Secondary Outcome Measures :
  1. Cost Effectiveness Measured as Index Procedural and Hospitalization Costs [ Time Frame: 1 year ]
    Costs for each strategy included the initial procedural costs and costs during the 1-year follow-up. The costs of the index procedures were calculated from the actual resource consumption by determining the amount of guiding catheters, regular wires, pressure wires, balloon dilatation catheters, stents, antiplatelet therapy, adenosine, contrast media, and hospital days used for each patient's index procedure. These were multiplied by the cost of each resource in US dollars. All costs were converted to 2008 US dollars using the consumer price index (www.bls.gov).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267774

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Catharina Hospital
Eindhoven, Netherlands
Sponsors and Collaborators
Stanford University
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Principal Investigator: Nico H Pijls Catharina Ziekenhuis Eindhoven
Principal Investigator: William F Fearon Stanford University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: William Fearon, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00267774    
Other Study ID Numbers: 3933
First Posted: December 21, 2005    Key Record Dates
Results First Posted: July 27, 2016
Last Update Posted: November 13, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases