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FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01132495
First received: May 20, 2010
Last updated: October 13, 2016
Last verified: October 2016
Results First Received: June 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Interventions: Other: Stenting plus OMT
Other: Standard of care

  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
Participants were randomized to Cohort A if at least one stenoses had an FFR value of <=0.80. Participants with FFR >0.80 were treated according to local practice and were randomized to study follow-up / no study follow-up in Cohort B. Therefore, participants are either in cohort A or cohort B (not both).

Reporting Groups
  Description
Cohort A - PCI Plus OMT

PCI plus optimal medical treatment

Stenting plus OMT: FFR guided PCI, plus OMT

Cohort A - OMT Alone

Optimal medical treatment alone

Standard of care: OMT alone

Cohort B - Follow-up Observation with treatment based on physician preference
Cohort B - No Follow-up Re-consented Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data

Participant Flow:   Overall Study
    Cohort A - PCI Plus OMT   Cohort A - OMT Alone   Cohort B - Follow-up   Cohort B - No Follow-up Re-consented
STARTED   447   441   166   116 
COMPLETED   407   403   146   104 
NOT COMPLETED   40   38   20   12 
Various reasons                40                38                20                12 



  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
Cohort A - PCI Plus OMT

PCI plus optimal medical treatment

Stenting plus OMT: FFR guided PCI, plus OMT

Cohort A - OMT Alone

Optimal medical treatment alone

Standard of care: OMT alone

Cohort B - Follow-up Observation with treatment based on physician preference
Cohort B - No Follow-up Re-consented Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
Total Total of all reporting groups

Baseline Measures
   Cohort A - PCI Plus OMT   Cohort A - OMT Alone   Cohort B - Follow-up   Cohort B - No Follow-up Re-consented   Total 
Overall Participants Analyzed 
[Units: Participants]
 447   441   166   116   1170 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.5  (9.3)   63.9  (9.6)   63.6  (9.8)   64.4  (8.8)   63.7  (9.4) 
Gender 
[Units: Participants]
         
Female   93   103   53   37   286 
Male   354   338   113   79   884 


  Outcome Measures

1.  Primary:   Major Adverse Cardiac Event Rate (MACE)   [ Time Frame: 24 Month ]

2.  Secondary:   Overall MACE   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   03/2018   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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sr. Director, Global Clinical Affairs
Organization: St. Jude Medical
phone: 651-756-5586
e-mail: jmifek@sjm.com


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01132495     History of Changes
Other Study ID Numbers: 0904
Study First Received: May 20, 2010
Results First Received: June 8, 2016
Last Updated: October 13, 2016
Health Authority: Belgium: Ethics Committee