TRANSFIX Zenith® Transection Clinical Study

Cook Research Incorporated50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thoracic Aorta Thoracic Injuries Blunt Injuries

Interventions

Zenith® TX2® Low Profile Endovascular GraftDEVICE

Treatment of Blunt thoracic aortic injuries (BTAIs)

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (21)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

All-cause Mortality

Time frame: 30 days

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

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

Data from ClinicalTrials.gov

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