TRANSFIX Zenith® Transection Clinical Study

Thoracic Injuries Clinical Trial

— TRANSFIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688050
• Other study ID #: 11-004
• Status: Completed
• Phase: N/A
• Start date: January 23, 2013
• Est. completion date: July 29, 2019

Study information

• Verified date: October 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 29, 2019
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Blunt Injuries
• Thoracic Aorta
• Thoracic Injuries
• Wounds and Injuries
• Wounds, Nonpenetrating

Intervention

Device:
• Zenith® TX2® Low Profile Endovascular Graft
Treatment of Blunt thoracic aortic injuries (BTAIs)

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Cooper University Hospital	Camden	New Jersey
United States	University of North Carolina Vascular Surgery	Chapel Hill	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University of Cincinnati University Hospital	Cincinnati	Ohio
United States	UT Southwestern Medical Center - Parkland Memorial Hospital	Dallas	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Tennessee Medical School	Knoxville	Tennessee
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck Hospital of USC	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami School of Medicine	Miami	Florida
United States	Rutgers University	Newark	New Jersey
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mercy Hospital St. Louis	Saint Louis	Missouri
United States	University of Washington - Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality		30 days
Primary	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.	30 days
Primary	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.	30 days