TRANSFIX Zenith® Transection Clinical Study
TRANSFIX
TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
1 other identifier
interventional
50
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedStudy Start
First participant enrolled
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedResults Posted
Study results publicly available
November 18, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2019
CompletedNovember 18, 2020
October 1, 2020
1.4 years
September 14, 2012
October 15, 2015
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
All-cause Mortality
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.
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.
30 days
Study Arms (1)
Endovascular Repair
EXPERIMENTALInterventions
Treatment of Blunt thoracic aortic injuries (BTAIs)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
University of Louisville
Louisville, Kentucky, 40292, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers University
Newark, New Jersey, 07103, United States
University of North Carolina Vascular Surgery
Chapel Hill, North Carolina, 27599, United States
University of Cincinnati University Hospital
Cincinnati, Ohio, 45267, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee Medical School
Knoxville, Tennessee, 37920, United States
UT Southwestern Medical Center - Parkland Memorial Hospital
Dallas, Texas, 75235, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (2)
Starnes BW, Dwivedi A, Giglia J, Woo K, Yeh C; TRANSFIX Study Investigators. Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. J Vasc Surg. 2020 Jun;71(6):1851-1857. doi: 10.1016/j.jvs.2019.05.070. Epub 2020 Feb 1.
PMID: 32014287DERIVEDStarnes BW, Dwivedi AJ, Giglia JS, Woo K, Yeh C; TRANSFIX Study Investigators. Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. J Vasc Surg. 2015 Dec;62(6):1495-503.e1. doi: 10.1016/j.jvs.2015.07.098. Epub 2015 Sep 26.
PMID: 26391458DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders,MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Starnes, MD
University of Washington - Harborview, Division of Vascular Surgery
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 19, 2012
Study Start
January 23, 2013
Primary Completion
June 1, 2014
Study Completion
July 29, 2019
Last Updated
November 18, 2020
Results First Posted
November 18, 2015
Record last verified: 2020-10