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Pivotal Study for the FLAIR Endovascular Stent Graft

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678249
First Posted: May 15, 2008
Last Update Posted: May 11, 2011
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.
Information provided by:
C. R. Bard
Results First Submitted: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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.
No text entered.

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 
Overall Participants Analyzed 
[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


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

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 ( Other Identifier: Food and Drug Administration )
First Submitted: May 13, 2008
First Posted: May 15, 2008
Results First Submitted: February 20, 2009
Results First Posted: May 9, 2011
Last Update Posted: May 11, 2011