Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection

July 26, 2017 updated by: W.L.Gore & Associates

Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta

TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
      • Stanford, California, United States
    • Florida
      • Jacksonville, Florida, United States
      • Tampa, Florida, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New York
      • Lake Success, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Temple, Texas, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Traumatic transection of the DTA that requires repair, determined by the treating physician
  2. Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
  3. Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
  4. Age greater than or equal to 18 years
  5. Proximal and distal landing zone length greater than or equal to 2.0 cm. Landing zones must be in native aorta. Landing zone may include left subclavian artery, if necessary
  6. All proximal and distal landing zone inner diameters are between 16-42 mm. Diameter assessed by flow lumen and thrombus, if present; calcium excluded
  7. Subject capable of complying with study protocol requirements, including follow-up
  8. Informed Consent Form signed by subject or legal representative

Exclusion Criteria:

  1. Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper
  2. Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
  3. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  4. Infected aorta
  5. Subject has a systemic infection and may be at increased risk of endovascular graft infection
  6. Planned coverage of left carotid or celiac arteries with the CTAG Device
  7. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  8. Treatment in another drug or medical device study within 1 year of study enrollment
  9. Known history of drug abuse
  10. Pregnant female
  11. Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
  12. Injury Severity Score of 75
  13. Subject has known sensitivities or allergies to the device materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GORE Conformable TAG® Thoracic Endoprosthesis
Device: Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality
Time Frame: 30 days post-treatment
30 days post-treatment
Major Device Events
Time Frame: 1 month post-treatment
Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.
1 month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Mark Farber, M.D., University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAG 08-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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