We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

TRANSFIX Zenith® Transection Clinical Study (TRANSFIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01688050
Recruitment Status : Active, not recruiting
First Posted : September 19, 2012
Results First Posted : November 18, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Thoracic Aorta Thoracic Injuries Blunt Injuries Device: Zenith® TX2® Low Profile Endovascular Graft

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
Study Start Date : January 2013
Primary Completion Date : June 2014
Estimated Study Completion Date : May 2019
Arms and Interventions

Arm Intervention/treatment
Experimental: Endovascular Repair Device: Zenith® TX2® Low Profile Endovascular Graft
Zenith® TX2® Low Profile Endovascular Graft
Other Name: Zenith Alpha Thoracic™ Endovascular Graft


Outcome Measures

Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: 30 days ]
  2. Aortic Injury-related Mortality [ Time Frame: 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.

  3. Device Success [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688050


  Show 21 Study Locations
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Benjamin Starnes, MD University of Washington - Harborview, Division of Vascular Surgery
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01688050     History of Changes
Other Study ID Numbers: 11-004
First Posted: September 19, 2012    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: January 17, 2018
Last Verified: December 2017

Keywords provided by Cook Group Incorporated:
Blunt thoracic aortic injury
Transection
Endovascular graft

Additional relevant MeSH terms:
Wounds and Injuries
Thoracic Injuries
Wounds, Nonpenetrating