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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00917852
First received: June 8, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention
Thoracic Injuries
Device: Gore Conformable TAG Thoracic Endoprosthesis

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • All Cause Mortality [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: November 2009
Estimated Study Completion Date: November 2016
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GORE Conformable TAG® Thoracic Endoprosthesis Device: Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917852

  Show 26 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Mark Farber, M.D. University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00917852     History of Changes
Other Study ID Numbers: TAG 08-02
Study First Received: June 8, 2009
Results First Received: April 4, 2012
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
aorta
trauma
transection

Additional relevant MeSH terms:
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014