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Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection

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: NCT00917852
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : May 1, 2012
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.

Condition or disease Intervention/treatment Phase
Thoracic Injuries Device: Gore Conformable TAG Thoracic Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GORE Conformable TAG® Thoracic Endoprosthesis Device: Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft

Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 30 days post-treatment ]
  2. Major Device Events [ Time Frame: 1 month post-treatment ]
    Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.

Information from the National Library of Medicine

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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. Traumatic transection of the DTA that requires repair, determined by the treating physician
  2. Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
  3. Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
  4. Age greater than or equal to 18 years
  5. Proximal and distal landing zone length greater than or equal to 2.0 cm. Landing zones must be in native aorta. Landing zone may include left subclavian artery, if necessary
  6. All proximal and distal landing zone inner diameters are between 16-42 mm. Diameter assessed by flow lumen and thrombus, if present; calcium excluded
  7. Subject capable of complying with study protocol requirements, including follow-up
  8. Informed Consent Form signed by subject or legal representative

Exclusion Criteria:

  1. Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper
  2. Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
  3. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  4. Infected aorta
  5. Subject has a systemic infection and may be at increased risk of endovascular graft infection
  6. Planned coverage of left carotid or celiac arteries with the CTAG Device
  7. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  8. Treatment in another drug or medical device study within 1 year of study enrollment
  9. Known history of drug abuse
  10. Pregnant female
  11. Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
  12. Injury Severity Score of 75
  13. Subject has known sensitivities or allergies to the device materials

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): NCT00917852

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United States, California
Los Angeles, California, United States
Stanford, California, United States
United States, Florida
Jacksonville, Florida, United States
Tampa, Florida, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
Lake Success, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Greenville, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
Temple, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
W.L.Gore & Associates
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Principal Investigator: Mark Farber, M.D. University of North Carolina, Chapel Hill
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: W.L.Gore & Associates Identifier: NCT00917852    
Other Study ID Numbers: TAG 08-02
First Posted: June 10, 2009    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: August 25, 2017
Last Verified: July 2017
Keywords provided by W.L.Gore & Associates:
Additional relevant MeSH terms:
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Thoracic Injuries
Wounds and Injuries