TRANSFIX Zenith® Transection Clinical Study

Not Applicable

Completed

• Conditions: Thoracic Aorta; Thoracic Injuries; Blunt Injuries
• Interventions: Device: Zenith® TX2® Low Profile Endovascular Graft

• Registration Number: NCT01688050
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Study Start: 2013-01-23
• Primary Completion: 2014-06
• Disposition First Submitted: 2015-07-28
• Disposition First Submitted QC: 2015-07-28
• Disposition First Posted: 2015-08-18
• Results First Submitted: 2015-10-15
• Results First Submitted QC: 2015-10-15
• Results First Posted: 2015-11-18
• Study Completion: 2019-07-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Repair	Zenith® TX2® Low Profile Endovascular Graft	-

Primary Outcome Measures

Name	Time	Method
All-cause Mortality	30 days
Aortic Injury-related Mortality	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	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.

Trial Locations

Locations (21)

UT Southwestern Medical Center - Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Mercy Hospital St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Rutgers University; 🇺🇸 Newark, New Jersey, United States

University of North Carolina Vascular Surgery; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Tennessee Medical School; 🇺🇸 Knoxville, Tennessee, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

University of Cincinnati University Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of Washington - Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States