VivaStent Feasibility Study

Exclusion Criteria

• •1 Presence of Dural Arteriovenous Fistula (AVF), cerebral vascular lesions, malformation, or aneurysm that can explain the pulsatile tinnitus on CTV or MRV.
• •2 Transverse-sigmoid sinus vessel size \<5 mm or \>10 mm. 3 Anemia, defined as Hb \< 8 g/dl. 4 Chronic renal failure Creatinine \> 1.6 mg/dl 5 History of stroke or transient ischemic attack (TIA). 6 History of severe carotid atherosclerotic disease. 7 History of AF or other stroke risk factors. 8 History of coagulopathy, hypercoagulability, deep vein thrombosis or pulmonary embolism.
• •9 History of severe chronic obstructive pulmonary disease (COPD) or other severe respiratory disease.
• •10 History of heart failure, dilated cardiomyopathy, or congenital heart conditions.
• •11 Pregnant (confirmed by a pregnancy test) or lactating woman 12 Otologic disorders, such as chronic hearing loss, or other ENT disorders that can cause tinnitus.
• •13 Allergic to iodinated contrast material despite premedication, or to Nitinol.
• •14 Contra-indication to aspirin, clopidogrel or other anticoagulants. 15 Protected adults, such as person subject to legal protection, person deprived of liberty, and person unable to express his consent.
• •16 Participating in another medical device or drug study.