Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

Aortic Aneurysm, Thoracic Clinical Trial

Official title:

A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590759
• Other study ID #: TAG 05-02
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: August 6, 2014
• Start date: August 2005
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Descending thoracic aortic aneurysm deemed to warrant surgical repair:

1. Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta

2. Saccular aneurysm

2. Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)

3. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

• <60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment

4. Life expectancy > 2 years

5. Surgical Candidate

• ASA Class I, II, III, or IV

• NYHA Class I, II, III or no heart disease

6. Male or infertile female

7. Minimum 21 years of age

8. Able to comply with protocol requirements

9. Signed Informed Consent Form

Exclusion Criteria:

1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta

2. Significant thrombus at the proximal or distal implantation zones

3. Mycotic aneurysm

4. Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)

5. Acute or chronic aortic dissection

6. Planned occlusion of the left carotid or celiac arteries

7. "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days

8. Myocardial infarction or cerebral vascular accident within 6 weeks

9. Severe respiratory insufficiency sufficient that precludes open thoracotomy

10. Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis

11. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

12. Participation in another investigational device or drug study within 1 year

13. Documented history of drug abuse within 6 months

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Intervention

Device:
• GORE TAG® Thoracic Endoprosthesis
implant

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	Aneurysm Related Death	Freedom from aneurysm related mortality for TAG 05-02 subjects	5 years	Yes
Secondary	A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.	Proportion of subjects in TAG 05-02 with MAEs	5 years	Yes