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

Thoracic Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00917852
• Other study ID #: TAG 08-02
• Status: Active, not recruiting
• Phase: N/A
• First received: June 8, 2009
• Last updated: March 2, 2015
• Start date: November 2009
• Est. completion date: November 2016

Study information

• Verified date: March 2015
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: November 2016
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thoracic Injuries

Intervention

Device:
• Gore Conformable TAG Thoracic Endoprosthesis
Endovascular stent graft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality		30 days post-treatment	Yes