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Trial record 8 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

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ClinicalTrials.gov Identifier: NCT00590759
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Aortic Aneurysm, Thoracic
Intervention: Device: GORE TAG® Thoracic Endoprosthesis

  Participant Flow

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
Thoracic Endograft GORE TAG® Thoracic Endoprosthesis: implant

Participant Flow:   Overall Study
    Thoracic Endograft
STARTED   150 
COMPLETED   70 
NOT COMPLETED   80 
Death                52 
Lost to Follow-up                28 



  Baseline Characteristics

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
Thoracic Endograft GORE TAG® Thoracic Endoprosthesis: implant

Baseline Measures
   Thoracic Endograft 
Overall Participants Analyzed 
[Units: Participants]
 150 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.1  (10.5) 
Gender 
[Units: Participants]
 
Female   48 
Male   102 
Region of Enrollment 
[Units: Participants]
 
United States   150 


  Outcome Measures

1.  Primary:   Aneurysm Related Death   [ Time Frame: 5 years ]

2.  Secondary:   A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Robert Makowsky
Organization: W. L. Gore and Associates, Inc.
phone: 6232345784
e-mail: rmakowsk@wlgore.com



Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00590759     History of Changes
Other Study ID Numbers: TAG 05-02
First Submitted: December 20, 2007
First Posted: January 11, 2008
Results First Submitted: June 10, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014