Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
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All Cause Mortality [ Time Frame: 30 days post-treatment ]
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)
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
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