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

Brief Summary:


Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.

Condition or disease Intervention/treatment Phase
Aneurysm, Dissecting Aortic Aneurysm, Thoracic Device: Endovascular Stent-graft repair of descending thoracic aorta Phase 3

Detailed Description:


There will be a maximum of 100 patients treated with the new device. You will be evaluated by your doctor to determine if you are able to participate in this research study. This evaluation will include reviewing your medical history, a physical examination, and special x-rays. These special x-rays are called CT scans and angiograms. Your doctor will explain what tests you will have done. A CT scan is a special x-ray that allows your doctor to see the size and shape of your aorta and your arteries. An angiogram uses a catheter (a hollow tube) that is placed into your arteries. Both tests use dye that can be seen on x-rays to see how the blood flows through your aorta and the surrounding arteries; for the CT scan it will be injected into a vein, and for the angiogram it is injected through the catheter into your arteries. These tests would be conducted whether or not you were participating in this research study. Your doctor will use this type of testing to determine if you are eligible to participate in this research study and as part of your follow-up care. Currently there are two aortic stent grafts manufactured by W.L. Gore & Associates that are approved by the FDA for experimental use. Your doctor will determine which device is more appropriate to treat your condition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.
Study Start Date : October 2001
Actual Primary Completion Date : July 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Arm - Placement of TAG device
A TAG device will be used to repair the pathology in the thoracic aorta
Device: Endovascular Stent-graft repair of descending thoracic aorta
A TAG device will be used to repair the pathology in the thoracic aorta

Primary Outcome Measures :
  1. Percentage of Participants With Technically Successful Implant [ Time Frame: Day 0 to Day 30 ]
    The percentage of participants with technically successful implantation as assessed by the investigator is reported.

Secondary Outcome Measures :
  1. Count of Participants Experiencing at Least One Endoleak Following Procedure [ Time Frame: Up to 60 months following procedure ]
    Endoleak is persistent blood flow in the aneurysm sac.

  2. Overall Survival [ Time Frame: 60 months ]
    Overall survival is reported as the count of participants alive 60 months following implant procedure.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients should be poor or high risk open surgical candidates.
  2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
  3. Anatomy meets TAG Endoprosthesis specification criteria.
  4. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

    • <60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment.
  5. Ability to comply with protocol requirements including follow-up.
  6. Signed Informed Consent

Exclusion Criteria:

  1. >4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
  2. Significant thrombus at the proximal or distal implantation sites.
  3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
  4. Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.

6. Female of child bearing age with positive pregnancy test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00757003

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Daniel Yung-Ho Sze Stanford University
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Responsible Party: Daniel Yung-Ho Sze, Principle Investigator, Stanford University Identifier: NCT00757003    
Other Study ID Numbers: SU-09112008-1299
13335 (SQL 73498) ( Other Identifier: Stanford University )
First Posted: September 22, 2008    Key Record Dates
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is made available upon request to colleagues conducting similar studies throughout the US.
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aortic Aneurysm
Aortic Diseases
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases