To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Trial ID or NCT#
PURPOSE OF RESEARCH: Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.
A Clinical Study of the TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Diseases for Non-Surgical Candidates Under the Physician Sponsored IDE.
- 1. Patients should be poor or high risk open surgical candidates. 2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection. 3. Anatomy meets TAG Endoprosthesis specification criteria. 4. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm - <60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment. 5. Ability to comply with protocol requirements including follow-up. 6. Signed Informed Consent
- 1. >4mm 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 sites. 3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided. 4. Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts. 6. Female of child bearing age with positive pregnancy test.
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