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

W.L. Gore & Associates

Status: Completed

Conditions: Thoracic Injuries

Treatments: Device: Gore Conformable TAG Thoracic Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917852

TAG 08-02

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

GORE Conformable TAG® Thoracic Endoprosthesis

Experimental group

Treatment:

Device: Gore Conformable TAG Thoracic Endoprosthesis