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

Not Applicable

Completed

• Conditions: Thoracic Injuries
• Interventions: Device: Gore Conformable TAG Thoracic Endoprosthesis

• Registration Number: NCT00917852
• Lead Sponsor: W.L.Gore & Associates

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Study Start: 2009-11
• Primary Completion: 2011-02
• Results First Submitted: 2012-04-04
• Results First Submitted QC: 2012-04-04
• Results First Posted: 2012-05-01
• Study Completion: 2017-02-28
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE Conformable TAG® Thoracic Endoprosthesis	Gore Conformable TAG Thoracic Endoprosthesis	-

Primary Outcome Measures

Name	Time	Method
All Cause Mortality	30 days post-treatment
Major Device Events	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.