Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
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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
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Descending thoracic aortic aneurysm deemed to warrant surgical repair:
Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
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
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
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