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

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.
ClinicalTrials.gov Identifier: NCT00608829
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : September 15, 2010
Last Update Posted : March 5, 2015
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
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 45mm TAG Device Subjects
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 23
Completed 8
Not Completed 15
Reason Not Completed
Death             6
Withdrawal by Subject             4
Subject refuses to follow up or return.             5
Arm/Group Title 45mm TAG Device Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
77.6  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
4
  17.4%
Male
19
  82.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Hide Description Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Time Frame one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 45mm TAG Device Subjects
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
11
Time Frame Up to 5 years of follow-up
Adverse Event Reporting Description Note: Major/Minor classification was collected. All events classified as 'Major' are in 'Serious adverse events', 'Minor' events are in 'Other adverse events'. Major adverse events were those resulting in: a)therapy and short hospitalization b)major therapy/increase in level of care/prolonged hospitalization c)permanent adverse sequelae or d)death.
 
Arm/Group Title 45mm TAG Device Subjects
Hide Arm/Group Description 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.
All-Cause Mortality
45mm TAG Device Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
45mm TAG Device Subjects
Affected / at Risk (%)
Total   17/23 (73.91%) 
Blood and lymphatic system disorders   
Bleeding Complication *  5/23 (21.74%) 
Cardiac disorders   
Cardiac Complication *  6/23 (26.09%) 
Gastrointestinal disorders   
Bowel Complication *  2/23 (8.70%) 
Infections and infestations   
Sepsis *  2/23 (8.70%) 
Injury, poisoning and procedural complications   
Endoleak *  3/23 (13.04%) 
Wound Complication *  2/23 (8.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm *  1/23 (4.35%) 
Nervous system disorders   
Neurologic Complication *  4/23 (17.39%) 
Renal and urinary disorders   
Genitourinary *  2/23 (8.70%) 
Renal Function Complication *  3/23 (13.04%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Complication *  5/23 (21.74%) 
Social circumstances   
Other Complication *  8/23 (34.78%) 
Vascular disorders   
Vascular Complication *  5/23 (21.74%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
45mm TAG Device Subjects
Affected / at Risk (%)
Total   19/23 (82.61%) 
Blood and lymphatic system disorders   
Bleeding Complication *  5/23 (21.74%) 
Cardiac disorders   
Cardiac Complication *  8/23 (34.78%) 
Gastrointestinal disorders   
Bowel Complication *  3/23 (13.04%) 
Injury, poisoning and procedural complications   
Endoleak *  10/23 (43.48%) 
Wound Complication *  2/23 (8.70%) 
Nervous system disorders   
Neurologic Complication *  5/23 (21.74%) 
Renal and urinary disorders   
Genitourinary *  3/23 (13.04%) 
Renal Function Complication *  4/23 (17.39%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Complication *  9/23 (39.13%) 
Social circumstances   
Other Complication *  12/23 (52.17%) 
Vascular disorders   
Vascular Complication *  2/23 (8.70%) 
*
Indicates events were collected by non-systematic assessment
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 continued for 5 years.
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.
Gore has the right to review disclosures, requesting a delay of more than 60 days but less than or equal to 180 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.
Results Point of Contact
Name/Title: Abe Letter
Organization: W.L. Gore and Associates
Phone: 928 864 3113
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00608829     History of Changes
Other Study ID Numbers: TAG 06-02
First Submitted: December 20, 2007
First Posted: February 6, 2008
Results First Submitted: August 18, 2010
Results First Posted: September 15, 2010
Last Update Posted: March 5, 2015