Thoracic Injuries
Conditions
Keywords
aorta, trauma, transection
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.
Interventions
DEVICEGore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE Conformable TAG® Device Surgical Implant | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
Baseline characteristics
| Characteristic | GORE Conformable TAG® Device Surgical Implant |
|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 19.9 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 51 |
| other Total, other adverse events | 48 / 51 |
| serious Total, serious adverse events | 27 / 51 |
Outcome results
Primary
All Cause Mortality
Time frame: 30 days post-treatment
Population: All enrolled subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | All Cause Mortality | 4 participants |
Primary
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.
Time frame: 1 month post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | Major Device Events | 0 Participants |