Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
NCT ID: NCT00917852
Last Updated: 2017-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2009-11-30
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GORE Conformable TAG® Thoracic Endoprosthesis
Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft
Interventions
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Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Farber, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Los Angeles, California, United States
Stanford, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Lake Success, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Temple, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.
Other Identifiers
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TAG 08-02
Identifier Type: -
Identifier Source: org_study_id
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