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Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

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ClinicalTrials.gov Identifier: NCT00908388
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : May 16, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type B Aortic Dissection
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
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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 Conformable TAG® Device Surgical Implant Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)

Participant Flow:   Overall Study
    GORE Conformable TAG® Device Surgical Implant
STARTED   50 
COMPLETED   40 
NOT COMPLETED   10 



  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
GORE Conformable TAG® Device Surgical Implant Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection

Baseline Measures
   GORE Conformable TAG® Device Surgical Implant 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.1  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  26.0% 
Male      37  74.0% 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures

1.  Primary:   All-cause Mortality Incidence Through 30 Days Post-treatment   [ Time Frame: 30 Days Post-Treatment ]

2.  Primary:   Exclusion of Primary Entry Tear   [ Time Frame: 1 month ]

3.  Secondary:   False Lumen Thrombosis   [ Time Frame: Last available follow-up through 5 years ]

4.  Secondary:   Aortic Rupture   [ Time Frame: Last available follow-up through 5 years ]

5.  Secondary:   Additional Dissection Based Intervention Rate   [ Time Frame: Last available follow-up through 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
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  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: Abe Letter
Organization: W.L. Gore & Associates
phone: 928-864-3113
e-mail: aletter@wlgore.com



Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00908388     History of Changes
Other Study ID Numbers: TAG 08-01
First Submitted: April 3, 2009
First Posted: May 25, 2009
Results First Submitted: October 24, 2013
Results First Posted: May 16, 2014
Last Update Posted: October 27, 2017