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

Study Overview
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Brief Summary
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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

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

Conditions
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Aortic Aneurysm, Thoracic

Intervention / Treatment
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* Device: GORE TAG® Thoracic Endoprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Descending thoracic aortic aneurysm deemed to warrant surgical repair: Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta Saccular aneurysm Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A) 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 Life expectancy > 2 years Surgical Candidate ASA Class I, II, III, or IV NYHA Class I, II, III or no heart disease Male or infertile female Minimum 21 years of age Able to comply with protocol requirements Signed Informed Consent Form Exclusion Criteria: 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta Significant thrombus at the proximal or distal implantation zones Mycotic aneurysm Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture) Acute or chronic aortic dissection Planned occlusion of the left carotid or celiac arteries Planned concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days Myocardial infarction or cerebral vascular accident within 6 weeks Severe respiratory insufficiency sufficient that precludes open thoracotomy Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome Participation in another investigational device or drug study within 1 year Documented history of drug abuse within 6 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GORE TAG® Thoracic Endoprosthesis<br> | Device: GORE TAG® Thoracic Endoprosthesis<br>* implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysm Related Death | Freedom from aneurysm related mortality for TAG 05-02 subjects | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |