Testing BosSTENT implantation for pulsatile tinnitus

Exclusion

• −History of severe allergy to contrast/contrast media or nickel
• −Previously implanted stent in the target vessel
• −Contraindication to anticoagulant and/or antiplatelet therapy or thrombolytic drugs
• −Target vessel size that does not fall within the indicated range per Table 1 of the IFU
• −Non-pulse-synchronous tinnitus
• −Current diagnosis of papilledema
• −Dural arteriovenous fistula or arteriovenous malformation
• −History of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke factors
• −History of deep vein thrombosis or pulmonary embolism
• −History of heart failure, dilated cardiomyopathy, or congenital heart conditions
• −Arterial stenosis, dissection, or aneurysm
• −PST due to causes not related to cerebral venous sinus stenosis
• −Evidence of an active systemic infection
• −Venous sinus thrombosis, jugular compression, venous aberrant or tortuous anatomy that would prevent the safe delivery and deployment of the BosSTENT to the target treatment zone.
• −Cerebral venous sinus diverticulum that, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, requires treatment other than stenting (e.g., coiling)
• −Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis
• −Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy
• −Suffered a stroke within the past 6 months
• −Platelet count \<100x109/L (100,000/µL)
• −Participation in another investigational protocolProtocolThe detailed plan a study must follow.Read more →
• −Immuno-compromised
• −Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and/or effective procedure
• −Incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Pregnant or nursing women (females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →)
• −Dural cerebral venous sinus stenosis secondary to an underlying condition (e.g. brain tumor) that may be treated by alternative established therapies (e.g., surgery, embolization)