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

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: 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Arm - Placement of TAG Device 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.

Participant Flow:   Overall Study
    Treatment Arm - Placement of TAG Device
STARTED   100 
COMPLETED   51 
NOT COMPLETED   49 
Death                33 
Lost to Follow-up                9 
Withdrawal by Subject                4 
Surgically explanted                2 
Not implanted                1 



  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
Treatment Arm - Placement of TAG Device 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.

Baseline Measures
   Treatment Arm - Placement of TAG Device 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.4  (17.4) 
Gender 
[Units: Participants]
Count of Participants
 
Female      31  31.0% 
Male      69  69.0% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Technically Successful Implant   [ Time Frame: Day 0 to Day 30 ]

2.  Secondary:   Count of Participants Experiencing at Least One Endoleak Following Procedure   [ Time Frame: Up to 60 months following procedure ]

3.  Secondary:   Overall Survival   [ Time Frame: 60 months ]


  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 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
e-mail: dansze@stanford.edu



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