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

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ClinicalTrials.gov Identifier: NCT00917852
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : May 1, 2012
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE June 8, 2009
First Posted Date  ICMJE June 10, 2009
Results First Submitted Date  ICMJE April 4, 2012
Results First Posted Date  ICMJE May 1, 2012
Last Update Posted Date August 25, 2017
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
Official Title  ICMJE Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thoracic Injuries
Intervention  ICMJE Device: Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft
Study Arms  ICMJE Experimental: GORE Conformable TAG® Thoracic Endoprosthesis
Intervention: Device: Gore Conformable TAG Thoracic Endoprosthesis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2011)
51
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00917852
Other Study ID Numbers  ICMJE TAG 08-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Farber, M.D. University of North Carolina, Chapel Hill
PRS Account W.L.Gore & Associates
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP