TRANSFIX Zenith® Transection Clinical Study

Completed · Not applicable

Conditions studied: Thoracic Aorta, Thoracic Injuries, Blunt Injuries

In brief

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.

Key facts

Study ID

NCT01688050

Run by

Cook Research Incorporated

People needed

50

Starts

2013-01-23

Expected to finish

2019-07-29

Last updated by the study team

2020-11-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Clinical considerations that would compromise patient safety or study outcomes
• Unsuitable arterial anatomy

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mercy Hospital St. Louis — St Louis, Missouri, 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 Cincinnati University Hospital — Cincinnati, Ohio, 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
• University of Tennessee Medical School — Knoxville, Tennessee, United States
• UT Southwestern Medical Center - Parkland Memorial Hospital — Dallas, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• University of Washington - Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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