NCT00267774

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 27, 2016

Completed
Last Updated

November 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

December 19, 2005

Results QC Date

June 17, 2016

Last Update Submit

October 10, 2017

Conditions

Coronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiac Events

    All cause death, Documented myocardial infarction, Repeat revascularization (PCI and/or CABG) as adjudicated by the Clinical Event Committee

    1 year

Secondary Outcomes (1)

  • Cost Effectiveness Measured as Index Procedural and Hospitalization Costs

    1 year

Study Arms (2)

FFR guided PCI

EXPERIMENTAL
Device: Fractional flow reserve

Angio-guided PCI

ACTIVE COMPARATOR
Procedure: Angio-guided PCI

Interventions

Fractional flow reserveDEVICE
FFR guided PCI
Angio-guided PCIPROCEDURE
Angio-guided PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\>/=18

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 21126973RESULT

  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom 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.

    PMID: 19144937RESULT

  • Nishi T, Piroth Z, De Bruyne B, Jagic N, Mobius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Juni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263.

    PMID: 30354650DERIVED

  • 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.

    PMID: 27056776DERIVED

  • van Nunen LX, Zimmermann FM, Tonino PA, Barbato E, Baumbach A, Engstrom 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.

    PMID: 26333474DERIVED

  • 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.

    PMID: 21903052DERIVED

  • Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom 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.

    PMID: 20537493DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
William F. Fearon, MD
Organization
Stanford University
wfearon@stanford.edu
650 725-2621

Study Officials

  • Nico H Pijls

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

  • William F Fearon

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 21, 2005

Study Start

January 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2015

Last Updated

November 13, 2017

Results First Posted

July 27, 2016

Record last verified: 2017-10

Locations

US(1)NL(1)