TRANSFIX Zenith® Transection Clinical Study (TRANSFIX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01688050
First received: September 14, 2012
Last updated: October 15, 2015
Last verified: October 2015
  Purpose
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 Intervention
Thoracic Aorta
Thoracic Injuries
Blunt Injuries
Device: Zenith® TX2® Low Profile Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury

Further study details as provided by Cook:

Primary Outcome Measures:
  • All-cause Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Aortic Injury-related Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: May 2019
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular Repair Device: Zenith® TX2® Low Profile Endovascular Graft
Zenith® TX2® Low Profile Endovascular Graft
Other Name: Zenith Alpha Thoracic™ Endovascular Graft

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688050

  Show 21 Study Locations
Sponsors and Collaborators
Cook
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
ClinicalTrials.gov Identifier: NCT01688050     History of Changes
Other Study ID Numbers: 11-004 
Study First Received: September 14, 2012
Results First Received: October 15, 2015
Last Updated: October 15, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 27, 2016