BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
This study is evaluating the safety and clinical performance of the BosSTENT, a new stent designed specifically for treating pulse-synchronous tinnitus due to venous sinus stenosis. The study will evaluate the long-term safety of the BosSTENT as well as its impact on the severity of pulse-synchronous tinnitus.
• 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