N/A
N=50
TRANSFIX Zenith® Transection Clinical Study
Thoracic Aorta · Thoracic Injuries · Blunt Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01688050 ↗Enrolled (actual)
50
Serious AEs
60.0%
Results posted
Nov 2015
Primary outcome: Primary: All-cause Mortality — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zenith® TX2® Low Profile Endovascular Graft (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Cook Research Incorporated
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
1 | — |
| PRIMARY Aortic Injury-related Mortality |
— | — |
| PRIMARY Device Success |
48 | — |
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.
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.