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

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.

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Key information

Conditions

Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
Infected aorta
Subject has a systemic infection and may be at increased risk of endovascular graft infection
Planned coverage of left carotid or celiac arteries with the CTAG Device
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Treatment in another drug or medical device study within 1 year of study enrollment
Known history of drug abuse
Pregnant female
Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
Injury Severity Score of 75
Subject has known sensitivities or allergies to the device materials

Treatment and study plan

Gore Conformable TAG Thoracic Endoprosthesis

Device

Endovascular stent graft

Primary outcomes

All Cause Mortality

Time frame: 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.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2017
First posted: Jun 10, 2009
Registry last updated: Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed