NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device

Exclusion Criteria

• •1. Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin
• •2. Subjects with contraindication to cerebral MRI
• •3. Subjects with a history of a stroke or transient ischemic attack within the prior 6 months
• •4. Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure
• •5. Renal insufficiency (creatinine \> 3.0 mg/dL or Glomerular Filtration Rate GFR \< 30) and/or renal replacement therapy at the time of screening
• •6. Subjects with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months
• •7. Subjects with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
• •8. Subject is currently participating in another drug or device clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation
• •9. Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI)
• •10. Subject requires an emergent procedure
• •11. Subject has active major psychiatric disease
• •12. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
• •13. Subject has an ejection fraction of 30% or less
• •14. Subjects with active endocarditis or other systemic infection
• •15. Subjects undergoing therapeutic thrombolysis
• •16. Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test
• •1. Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch
• •2. Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation
• •3. Subjects with a diameter of the ascending aorta \< 25 and \> 39 mm at baseline CT (measured 10 mm upstream of the first vessel of the brachiocephalic trunk)
• •4. Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
• •5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access
• •6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous