Trial record 1 of 80 for:    Open Studies | "Thoracic Injuries"
Previous Study | Return to List | Next Study

TRANSFIX Zenith® Transection Clinical Study

This study is currently recruiting participants.
Verified January 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01688050
First received: September 14, 2012
Last updated: January 31, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: May 2019
Estimated 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

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

Contacts
Contact: Alison J. Conovaloff, MS 765-463-7537 aconovaloff@medinst.com

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

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01688050     History of Changes
Other Study ID Numbers: 11-004
Study First Received: September 14, 2012
Last Updated: January 31, 2014
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, Nonpenetrating
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014