GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00608829
First received: December 20, 2007
Last updated: September 23, 2013
Last verified: September 2013
Results First Received: August 18, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aortic Aneurysm, Thoracic
Intervention: Device: GORE TAG® Thoracic Endoprosthesis

  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
No text entered.

Reporting Groups
  Description
45mm TAG Device Subjects The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.

Participant Flow:   Overall Study
    45mm TAG Device Subjects  
STARTED     23  
COMPLETED     17 [1]
NOT COMPLETED     6  
Death                 4  
Withdrawal by Subject                 1  
Subject refuses to follow up or return.                 1  
[1] Follow up is ongoing for 5 years for subjects remaining in the study



  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
45mm TAG Device Subjects The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.

Baseline Measures
    45mm TAG Device Subjects  
Number of Participants  
[units: participants]
  23  
Age  
[units: years]
Mean ± Standard Deviation
  77.6  ± 6.2  
Gender  
[units: participants]
 
Female     4  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     23  



  Outcome Measures

1.  Primary:   Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment   [ Time Frame: one year ]


  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
Enrollment into this trial was completed prematurely with 23 enrolled subjects. The 45mm TAG Device was approved based on the data collected and a descriptive statistical analysis. Follow up of enrolled subjects will continue for 5 years.


  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: Tab Bonny
Organization: W.L. Gore and Associates
phone: 928 864 4275
e-mail: tbonny@wlgore.com


No publications provided


Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00608829     History of Changes
Other Study ID Numbers: TAG 06-02
Study First Received: December 20, 2007
Results First Received: August 18, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration