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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Fearon, Stanford University
ClinicalTrials.gov Identifier:
NCT00267774
First received: December 19, 2005
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: June 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Arteriosclerosis
Interventions: Device: Fractional flow reserve
Procedure: Angio-guided PCI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FFR Guided PCI Fractional flow reserve
Angio-guided PCI Angio-guided PCI

Participant Flow:   Overall Study
    FFR Guided PCI     Angio-guided PCI  
STARTED     509     496  
COMPLETED     509     496  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FFR Guided PCI Fractional flow reserve
Angio-guided PCI Angio-guided PCI
Total Total of all reporting groups

Baseline Measures
    FFR Guided PCI     Angio-guided PCI     Total  
Number of Participants  
[units: participants]
  509     496     1005  
Age  
[units: years]
Mean (Standard Deviation)
  64.6  (10.3)     64.2  (10.2)     64.4  (10.3)  
Gender  
[units: participants]
     
Female     125     136     261  
Male     384     360     744  



  Outcome Measures

1.  Primary:   Major Adverse Cardiac Events   [ Time Frame: 1 year ]

2.  Secondary:   Cost Effectiveness   [ Time Frame: Index procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William F. Fearon, MD
Organization: Stanford University
phone: 650 725-2621
e-mail: wfearon@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: William Fearon, Stanford University
ClinicalTrials.gov Identifier: NCT00267774     History of Changes
Other Study ID Numbers: 3933
Study First Received: December 19, 2005
Results First Received: June 17, 2016
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board