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TRANSFIX Zenith® Transection Clinical Study (TRANSFIX)

Primary Purpose

Thoracic Aorta, Thoracic Injuries, Blunt Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenith® TX2® Low Profile Endovascular Graft
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aorta focused on measuring Blunt thoracic aortic injury, Transection, Endovascular graft

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Keck Hospital of USC
  • Cedars-Sinai Medical Center
  • University of Miami School of Medicine
  • Grady Memorial Hospital
  • University of Louisville
  • University of Maryland Medical Center
  • University of Mississippi Medical Center
  • Mercy Hospital St. Louis
  • Cooper University Hospital
  • Hackensack University Medical Center
  • Rutgers University
  • University of North Carolina Vascular Surgery
  • University of Cincinnati University Hospital
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • University of Tennessee Medical School
  • UT Southwestern Medical Center - Parkland Memorial Hospital
  • University of Virginia Medical Center
  • University of Washington - Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Repair

Arm Description

Outcomes

Primary Outcome Measures

All-cause Mortality
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2012
Last Updated
October 30, 2020
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01688050
Brief Title
TRANSFIX Zenith® Transection Clinical Study
Acronym
TRANSFIX
Official Title
TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2013 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aorta, Thoracic Injuries, Blunt Injuries
Keywords
Blunt thoracic aortic injury, Transection, Endovascular graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Repair
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Zenith® TX2® Low Profile Endovascular Graft
Other Intervention Name(s)
Zenith Alpha Thoracic™ Endovascular Graft
Intervention Description
Treatment of Blunt thoracic aortic injuries (BTAIs)
Primary Outcome Measure Information:
Title
All-cause Mortality
Time Frame
30 days
Title
Aortic Injury-related Mortality
Description
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.
Time Frame
30 days
Title
Device Success
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Starnes, MD
Organizational Affiliation
University of Washington - Harborview, Division of Vascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers University
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University of North Carolina Vascular Surgery
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Cincinnati University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Tennessee Medical School
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
UT Southwestern Medical Center - Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington - Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32014287
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.
Results Reference
derived
PubMed Identifier
26391458
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.
Results Reference
derived

Learn more about this trial

TRANSFIX Zenith® Transection Clinical Study

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