Clinical trial NCT00917852: Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
Official title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Injuries
Keywords: aorta
trauma
transection
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: All Cause Mortality
timeFrame: 30 days post-treatment
measure: Major Device Events
timeFrame: 1 month post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Stanford
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Lake Success
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Farber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.