BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus

Inclusion criteria

• Male or female ≥18 - 80 years old
• Able to provide informed consent to participate in the study
• Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.
• Cerebral venous sinus stenosis with the following characteristics:

• Transverse cerebral venous sinus
• >50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography
• Vessel diameter amenable to sizing according to Table 1 below without the need to undersize
• Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)
• Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up
• Life expectancy >12 months

Exclusion criteria

• 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)
• 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
• History of severe allergy to contrast/contrast media or nickel
• 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 Investigator'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 protocol
• Immuno-compromised
• 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 inclusion)
• 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 consent