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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267774
First Posted: December 21, 2005
Last Update Posted: July 27, 2016
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.
Information provided by (Responsible Party):
William Fearon, Stanford University
  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.

Condition Intervention
Coronary Arteriosclerosis Device: Fractional flow reserve Procedure: Angio-guided PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by William Fearon, Stanford University:

Primary Outcome Measures:
  • Major Adverse Cardiac Events [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Cost Effectiveness [ Time Frame: Index procedure ]

Enrollment: 1005
Study Start Date: January 2006
Study Completion Date: September 2015
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FFR guided PCI Device: Fractional flow reserve
Active Comparator: Angio-guided PCI Procedure: Angio-guided PCI

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Netherlands
Catharina Hospital
Eindhoven, Netherlands
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Nico H Pijls Catharina Ziekenhuis Eindhoven
Principal Investigator: William F Fearon Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Kobayashi Y, Nam CW, Tonino PA, Kimura T, De Bruyne B, Pijls NH, Fearon WF; FAME Study Investigators. The Prognostic Value of Residual Coronary Stenoses After Functionally Complete Revascularization. J Am Coll Cardiol. 2016 Apr 12;67(14):1701-11. doi: 10.1016/j.jacc.2016.01.056.
van Nunen LX, Zimmermann FM, Tonino PA, Barbato E, Baumbach A, Engstrøm T, Klauss V, MacCarthy PA, Manoharan G, Oldroyd KG, Ver Lee PN, Van't Veer M, Fearon WF, De Bruyne B, Pijls NH; FAME Study Investigators. Fractional flow reserve versus angiography for guidance of PCI in patients with multivessel coronary artery disease (FAME): 5-year follow-up of a randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1853-60. doi: 10.1016/S0140-6736(15)00057-4. Epub 2015 Aug 30.
Nam CW, Mangiacapra F, Entjes R, Chung IS, Sels JW, Tonino PA, De Bruyne B, Pijls NH, Fearon WF; FAME Study Investigators. Functional SYNTAX score for risk assessment in multivessel coronary artery disease. J Am Coll Cardiol. 2011 Sep 13;58(12):1211-8. doi: 10.1016/j.jacc.2011.06.020.
Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.
Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

Responsible Party: William Fearon, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00267774     History of Changes
Other Study ID Numbers: 3933
First Submitted: December 19, 2005
First Posted: December 21, 2005
Results First Submitted: June 17, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases


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