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

Completed · Not applicable

Conditions studied: Thoracic Injuries

In brief

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.

Key facts

Study ID

NCT00917852

Run by

W.L.Gore & Associates

People needed

51

Starts

2009-11-01

Expected to finish

2017-02-28

Last updated by the study team

2017-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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