N/A
Completed N=50
TRANSFIX Zenith® Transection Clinical Study
Thoracic Aorta · Thoracic Injuries · Blunt Injuries
Source: ClinicalTrials.gov NCT01688050 ↗
Enrolled (actual)
50
Serious AEs
60.0%
Results posted
Nov 2015
Primary outcomePrimary: All-cause Mortality — 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
1 | — |
| PRIMARY Aortic Injury-related Mortality |
— | — |
| PRIMARY Device Success |
48 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01688050). 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. Informational only — not medical advice.