Status:
COMPLETED
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Thoracic Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Traumatic transection of the DTA that requires repair, determined by the treating physician
- Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
- Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
- Age greater than or equal to 18 years
- 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
- All proximal and distal landing zone inner diameters are between 16-42 mm. Diameter assessed by flow lumen and thrombus, if present; calcium excluded
- Subject capable of complying with study protocol requirements, including follow-up
- Informed Consent Form signed by subject or legal representative
Exclusion
- 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
- Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
- Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
- Infected aorta
- Subject has a systemic infection and may be at increased risk of endovascular graft infection
- Planned coverage of left carotid or celiac arteries with the CTAG Device
- Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Treatment in another drug or medical device study within 1 year of study enrollment
- Known history of drug abuse
- Pregnant female
- Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
- Injury Severity Score of 75
- Subject has known sensitivities or allergies to the device materials
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00917852
Start Date
November 1 2009
End Date
February 28 2017
Last Update
August 25 2017
Active Locations (26)
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1
Los Angeles, California, United States
2
Stanford, California, United States
3
Jacksonville, Florida, United States
4
Tampa, Florida, United States