ADVANCE Direct Aortic Study

Exclusion Criteria

• •1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
• •2. Sepsis, including active endocarditis
• •3. Recent myocardial infarction (\<30 days)
• •4. Left ventricular or atrial thrombus by echocardiography
• •5. Uncontrolled atrial fibrillation
• •6. Mitral or tricuspid valvular insufficiency (\>grade II)
• •7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
• •8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• •9. Patients with:
• •1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
• •2. Symptomatic carotid or vertebral arterial narrowing (\>70%) disease, or
• •3. Thoracic aortic aneurysm in the path of delivery system
• •10. Bleeding diathesis or coagulopathy
• •11. Patient refuses blood transfusion
• •12. Estimated life expectancy of less than 12 months unless TAVI is performed
• •13. Creatine clearance \<20 mL/min
• •14. Active gastritis or peptic ulcer disease
• •15. Pregnancy or intent to become pregnant during study follow up
• •16. Patient is participating in another trial that may influence the results of this study
• •\-