Blunt Injuries, Thoracic Aorta, Thoracic Injuries
Conditions
Keywords
Blunt thoracic aortic injury, Transection, Endovascular graft
Brief summary
The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.
Interventions
DEVICEZenith® TX2® Low Profile Endovascular Graft
Treatment of Blunt thoracic aortic injuries (BTAIs)
Sponsors
Cook Research Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Vessels suitable for endovascular access and stent graft placement * Blunt thoracic aortic injury of the descending thoracic aorta * At least 16 years of age * Informed consent given by patient or legally authorized representative
Exclusion criteria
* Clinical considerations that would compromise patient safety or study outcomes * Unsuitable arterial anatomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | 30 days | Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair. |
| All-cause Mortality | 30 days | — |
| Aortic Injury-related Mortality | 30 days | Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Repair Zenith® TX2® Low Profile Endovascular Graft | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to open repair | 1 |
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Endovascular Repair |
|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 18.7 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 50 |
| other Total, other adverse events | 21 / 50 |
| serious Total, serious adverse events | 30 / 50 |
Outcome results
Primary
All-cause Mortality
Time frame: 30 days
Population: One death was adjudicated as unrelated by the Clinical Events Committee (CEC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Repair | All-cause Mortality | 1 participants |
95% CI: [0, 5.88]
Primary
Aortic Injury-related Mortality
Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Repair | Aortic Injury-related Mortality | 0 participants |
95% CI: [0, 7.1]
Primary
Device Success
Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.
Time frame: 30 days
Population: One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Repair | Device Success | 48 participants |
95% CI: [90.6, 100]