N/A
N=51
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
Thoracic Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00917852 ↗Enrolled (actual)
51
Serious AEs
52.9%
Results posted
May 2012
Primary outcome: Primary: All Cause Mortality — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gore Conformable TAG Thoracic Endoprosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Mortality |
4 | — |
| PRIMARY Major Device Events |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00917852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.