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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 : Completed
First Posted : September 19, 2012
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Study Description
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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 Phase
Thoracic Aorta Thoracic Injuries Blunt Injuries Device: Zenith® TX2® Low Profile Endovascular Graft Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
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
Actual Study Start Date : January 23, 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 29, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Endovascular Repair Device: Zenith® TX2® Low Profile Endovascular Graft
Treatment of Blunt thoracic aortic injuries (BTAIs)
Other Name: Zenith Alpha Thoracic™ Endovascular Graft


Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Benjamin Starnes, MD University of Washington - Harborview, Division of Vascular Surgery
  Study Documents (Full-Text)

Documents provided by Cook Group Incorporated ( Cook Research Incorporated ):
Study Protocol and Statistical Analysis Plan  [PDF] June 14, 2012

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT01688050    
Other Study ID Numbers: 11-004
First Posted: September 19, 2012    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Blunt thoracic aortic injury
Transection
Endovascular graft
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Wounds and Injuries
Thoracic Injuries
Wounds, Nonpenetrating
 Aneurysm
Vascular Diseases
Cardiovascular Diseases