Overview

This trial is active, not recruiting.

Conditions thoracic aorta, thoracic injuries, blunt injuries
Treatment zenith® tx2® low profile endovascular graft
Sponsor Cook
Start date January 2013
End date June 2014
Trial size 50 participants
Trial identifier NCT01688050, 11-004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
zenith® tx2® low profile endovascular graft Zenith Alpha Thoracic™ Endovascular Graft
Zenith® TX2® Low Profile Endovascular Graft

Primary Outcomes

Measure
All-cause Mortality
time frame: 30 days
Aortic Injury-related Mortality
time frame: 30 days
Device Success
time frame: 30 days

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Principal investigator Benjamin Starnes, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cook.