TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracic Aorta
- Sponsor
- Cook Research Incorporated
- Enrollment
- 50
- Locations
- 21
- Primary Endpoint
- All-cause Mortality
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
All-cause Mortality
Time Frame: 30 days
Aortic Injury-related Mortality
Time Frame: 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.
Device Success
Time Frame: 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.