Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00874250
First received: March 31, 2009
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: September 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aneurysm
Intervention: Device: GORE CTAG Device

  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
GORE CTAG Device The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Participant Flow:   Overall Study
    GORE CTAG Device  
STARTED     51  
COMPLETED     0  
NOT COMPLETED     51  



  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
GORE CTAG Device The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Baseline Measures
    GORE CTAG Device  
Number of Participants  
[units: participants]
  51  
Age  
[units: years]
Mean ± Standard Deviation
  71.9  ± 9.8  
Gender  
[units: participants]
 
Female     17  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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1.  Primary:   The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment   [ Time Frame: Treatment through 1 month post treatment ]

2.  Secondary:   The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.   [ Time Frame: Treatment through 1 month post procedure ]

3.  Secondary:   Procedure Time (Minutes)   [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]

4.  Secondary:   Operative Blood Loss (mL)   [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]

5.  Secondary:   Days of Convalescence Stay in an Intensive Care Unit   [ Time Frame: During the Index Hospitalization ]

6.  Secondary:   Total Length of Hospital Stay (Days)   [ Time Frame: Total Duration of the Index Hospitalization ]

7.  Secondary:   Time in Days to Return to Normal Daily Activities   [ Time Frame: Average time of one month ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Bill Caldwell
Organization: W.L. Gore and Associates
phone: 6232345687
e-mail: bicaldwe@wlgore.com


No publications provided


Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00874250     History of Changes
Other Study ID Numbers: TAG 08-03
Study First Received: March 31, 2009
Results First Received: September 22, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration