Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )

Tracking Information
First Submitted Date  ICMJE September 14, 2012
First Posted Date  ICMJE September 19, 2012
Results First Submitted Date  ICMJE October 15, 2015
Results First Posted Date  ICMJE November 18, 2015
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE January 23, 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
  • All-cause Mortality [ Time Frame: 30 days ]
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRANSFIX Zenith® Transection Clinical Study
Official Title  ICMJE TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thoracic Aorta
  • Thoracic Injuries
  • Blunt Injuries
Intervention  ICMJE Device: Zenith® TX2® Low Profile Endovascular Graft
Treatment of Blunt thoracic aortic injuries (BTAIs)
Other Name: Zenith Alpha Thoracic™ Endovascular Graft
Study Arms  ICMJE Experimental: Endovascular Repair
Intervention: Device: Zenith® TX2® Low Profile Endovascular Graft
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 29, 2019
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01688050
Other Study ID Numbers  ICMJE 11-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cook Group Incorporated ( Cook Research Incorporated )
Study Sponsor  ICMJE Cook Research Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin Starnes, MD University of Washington - Harborview, Division of Vascular Surgery
PRS Account Cook Group Incorporated
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP