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To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease

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ClinicalTrials.gov Identifier: NCT00757003
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Yung-Ho Sze, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Intervention Device: Endovascular Stent-graft repair of descending thoracic aorta
Enrollment 100
Recruitment Details Enrollment October 2000 - November 2007. Patients presenting or transferred to Stanford University Medical Center with thoracic aortic pathology deemed prohibitively high risk for open surgical repair.
Pre-assignment Details  
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Period Title: Overall Study
Started 100
Completed 51
Not Completed 49
Reason Not Completed
Death             33
Lost to Follow-up             9
Withdrawal by Subject             4
Surgically explanted             2
Not implanted             1
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
64.4  (17.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
31
  31.0%
Male
69
  69.0%
1.Primary Outcome
Title Percentage of Participants With Technically Successful Implant
Hide Description The percentage of participants with technically successful implantation as assessed by the investigator is reported.
Time Frame Day 0 to Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description:
Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
99.0
2.Secondary Outcome
Title Count of Participants Experiencing at Least One Endoleak Following Procedure
Hide Description Endoleak is persistent blood flow in the aneurysm sac.
Time Frame Up to 60 months following procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description:

A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta

Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta

Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
32
  32.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is reported as the count of participants alive 60 months following implant procedure.
Time Frame 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description:
Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
Overall Number of Participants Analyzed 84
Measure Type: Count of Participants
Unit of Measure: Participants
51
  60.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm - Placement of TAG Device
Hide Arm/Group Description

A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta

Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta

All-Cause Mortality
Treatment Arm - Placement of TAG Device
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm - Placement of TAG Device
Affected / at Risk (%) # Events
Total   43/100 (43.00%)    
Cardiac disorders   
cardiac arrhythmia   21/100 (21.00%)  21
angina  6/100 (6.00%)  6
Gastrointestinal disorders   
bowel ischemia  3/100 (3.00%)  3
Nervous system disorders   
change in mental status  11/100 (11.00%)  11
cerebrovascular accident  8/100 (8.00%)  8
paraplegia/paraparesis  1/100 (1.00%)  1
Renal and urinary disorders   
renal failure  9/100 (9.00%)  9
renal insufficiency  7/100 (7.00%)  7
urinary tract infection  4/100 (4.00%)  4
Respiratory, thoracic and mediastinal disorders   
Atelectasis/Pneumonia   28/100 (28.00%)  28
respiratory failure  13/100 (13.00%)  13
pulmonary embolism  12/100 (12.00%)  12
Skin and subcutaneous tissue disorders   
lymphocele  4/100 (4.00%)  4
Surgical and medical procedures   
procedural hemorrhage  12/100 (12.00%)  12
type I endoleak  13/100 (13.00%)  13
type II endoleak  7/100 (7.00%)  7
access failure  1/100 (1.00%)  1
Vascular disorders   
thrombosis  3/100 (3.00%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm - Placement of TAG Device
Affected / at Risk (%) # Events
Total   16/100 (16.00%)    
Vascular disorders   
aortic diameter enlargement  16/100 (16.00%)  16
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Daniel Sze, Principal Investigator
Organization: Stanford University
Phone: 650-723-0728
Responsible Party: Daniel Yung-Ho Sze, Stanford University
ClinicalTrials.gov Identifier: NCT00757003     History of Changes
Other Study ID Numbers: SU-09112008-1299
13335 (SQL 73498) ( Other Identifier: Stanford University )
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: January 10, 2017
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017