TRANSFIX Zenith® Transection Clinical Study

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.

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Key information

Conditions

Thoracic Aorta Blunt Injuries Thoracic Injuries Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenith® TX2® Low Profile Endovascular Graft

Device

Treatment of Blunt thoracic aortic injuries (BTAIs)

Other names: Zenith Alpha Thoracic™ Endovascular Graft

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.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury

Acronym: TRANSFIX

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2019
First posted: Sep 19, 2012
Registry last updated: Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed