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. 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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Coronary Arteriosclerosis
Interventions: Device: Fractional flow reserve
Procedure: Angio-guided PCI

  Participant Flow

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
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Reporting Groups
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 

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 509   496   1005 
[Units: Years]
Mean (Standard Deviation)
 64.6  (10.3)   64.2  (10.2)   64.4  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      125  24.6%      136  27.4%      261  26.0% 
Male      384  75.4%      360  72.6%      744  74.0% 

  Outcome Measures

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

2.  Secondary:   Cost Effectiveness Measured as Index Procedural and Hospitalization Costs   [ Time Frame: 1 year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: William Fearon, Stanford University 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: November 13, 2017