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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta

Conditions
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Thoracic Injuries

Intervention / Treatment
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* Device: Gore Conformable TAG Thoracic Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE Conformable TAG® Thoracic Endoprosthesis<br> | Device: Gore Conformable TAG Thoracic Endoprosthesis<br>* Endovascular stent graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | 30 days post-treatment | 
| Major Device Events | 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. | 1 month post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aorta, trauma, transection