Pivotal Study for the FLAIR Endovascular Stent Graft

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00678249
First received: May 13, 2008
Last updated: May 10, 2011
Last verified: May 2011
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stenoses
Interventions: Device: FLAIR Endovascular Stent Graft
Procedure: PTA

  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
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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
  Description
FLAIR Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
PTA Only Percutaneous Transluminal Angioplasty
FLAIR Roll-In Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.

Participant Flow:   Overall Study
    FLAIR     PTA Only     FLAIR Roll-In Participants  
STARTED     97     93     37  
COMPLETED     97     93     37  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
FLAIR Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
PTA Only Percutaneous Transluminal Angioplasty
FLAIR Roll-In Participants Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
Total Total of all reporting groups

Baseline Measures
    FLAIR     PTA Only     FLAIR Roll-In Participants     Total  
Number of Participants  
[units: participants]
  97     93     37     227  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     52     50     21     123  
>=65 years     45     43     16     104  
Age  
[units: years]
Mean ± Standard Deviation
  61.83  ± 14.63     59.83  ± 13.58     62.16  ± 11.84     60.36  ± 14.09  
Gender  
[units: participants]
       
Female     64     57     23     144  
Male     33     36     14     83  
Region of Enrollment  
[units: participants]
       
United States     97     93     37     227  



  Outcome Measures
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1.  Primary:   Percent of Participants With Treatment Area Primary Patency (TAPP)   [ Time Frame: 6 month follow-up ]

2.  Secondary:   Total Number of Adverse Events   [ Time Frame: 6 month Follow-Up ]

3.  Secondary:   Percent of Participants With Successful Delivery of the Device   [ Time Frame: Index Procedure ]

4.  Secondary:   Percent of Participants With Procedural Success   [ Time Frame: Index Procedure ]

5.  Secondary:   Percent of Participants With TAPP   [ Time Frame: 2 month Follow-Up ]

6.  Secondary:   Percent of Participants With Access Circuit Primary Patency (ACPP)   [ Time Frame: 6 month Follow-Up ]

7.  Secondary:   Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)   [ Time Frame: 6 month Follow-Up ]

8.  Secondary:   Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)   [ Time Frame: 6 month Follow-Up ]

9.  Secondary:   Percent of Participants With Binary Restenosis   [ Time Frame: 6 month Follow-Up ]


  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: John Reviere, Director, Clinical Affairs
Organization: Bard Peripheral Vascular, Inc.
phone: 480-303-2644
e-mail: john.reviere@crbard.com


No publications provided by C. R. Bard

Publications automatically indexed to this study:

Responsible Party: John Reviere, Director, Clinical Affairs, Bard Peripheral Vascular, Inc.
ClinicalTrials.gov Identifier: NCT00678249     History of Changes
Other Study ID Numbers: IMP-9809, P060002
Study First Received: May 13, 2008
Results First Received: February 20, 2009
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration