Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Exclusion Criteria

• •1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
• •2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
• •3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
• •4. Subject with target aneurysm previously treated with a stent or flow diverter.
• •5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
• •6. Subject with a confirmed stenosis in parent artery.
• •7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
• •8. Subject has a pre-procedure mRS \>2.
• •9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
• •10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
• •11. Known serious sensitivity to radiographic contrast agents.
• •12. Known sensitivity to nickel, titanium metals, or their alloys.
• •13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
• •14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30.
• •15. Subject who has a contraindication to MRI or angiography for whatever reason.
• •16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
• •17. Subject with any known allergy to heparin, ASA or other antiplatelet medications.
• •18. Subject with coagulation disorder
• •19. Pregnant woman or breast feeding.
• •20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.