Clinical trial NCT01688050: TRANSFIX Zenith® Transection Clinical Study
Official title: TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aorta
Thoracic Injuries
Blunt Injuries
Keywords: Blunt thoracic aortic injury
Transection
Endovascular graft
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause Mortality
timeFrame: 30 days
measure: Aortic Injury-related Mortality
timeFrame: 30 days
measure: Device Success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina Vascular Surgery
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati University Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Knoxville
country: United States
facility: University of Tennessee Medical School
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Parkland Memorial Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington - Harborview, Division of Vascular Surgery
name: Benjamin Starnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Starnes 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.