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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
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Thoracic Endograft
Hide Arm/Group Description GORE TAG® Thoracic Endoprosthesis: implant
Period Title: Overall Study
Started 150
Completed 70
Not Completed 80
Reason Not Completed
Death             52
Lost to Follow-up             28
Arm/Group Title Thoracic Endograft
Hide Arm/Group Description GORE TAG® Thoracic Endoprosthesis: implant
Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
72.1  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
48
  32.0%
Male
102
  68.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants
150
1.Primary Outcome
Title Aneurysm Related Death
Hide Description Freedom from aneurysm related mortality for TAG 05-02 subjects
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thoracic Endograft
Hide Arm/Group Description:
GORE TAG® Thoracic Endoprosthesis: implant
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
Hide Description Proportion of subjects in TAG 05-02 with MAEs
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Thoracic Endograft
Hide Arm/Group Description:
GORE TAG® Thoracic Endoprosthesis: implant
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
22
Time Frame Total Study Follow-up.
Adverse Event Reporting Description Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
 
Arm/Group Title 0502 TAG Device Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
0502 TAG Device Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0502 TAG Device Subjects
Affected / at Risk (%)
Total   0/150 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0502 TAG Device Subjects
Affected / at Risk (%)
Total   147/150 (98.00%) 
Blood and lymphatic system disorders   
Bleeding Complication  52/150 (34.67%) 
Cardiac disorders   
Cardiac Complication  64/150 (42.67%) 
Gastrointestinal disorders   
Bowel Complication  54/150 (36.00%) 
General disorders   
Additional Implantation  16/150 (10.67%) 
Other Complication  102/150 (68.00%) 
Injury, poisoning and procedural complications   
Endoleak  58/150 (38.67%) 
Wound Complication  43/150 (28.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm  15/150 (10.00%) 
Nervous system disorders   
Neurologic Complication  62/150 (41.33%) 
Renal and urinary disorders   
Genitourinary  40/150 (26.67%) 
Renal Function Complication  26/150 (17.33%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Complication  67/150 (44.67%) 
Vascular disorders   
Vascular Complication  56/150 (37.33%) 
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 less than 90 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: Robert Makowsky
Organization: W. L. Gore and Associates, Inc.
Phone: 6232345784
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