[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sonorous NV, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100598330","bosstent-implantation-to-treat-pulse-synchronous-tinnitus-100598330",false,"NCT07070089","BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus","BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus","B-SILENT","Inclusion Criteria:\n\n1. Male or female ≥18 - 80 years old\n2. Able to provide informed consent to participate in the study\n3. Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.\n4. Cerebral venous sinus stenosis with the following characteristics:\n\n   1. Transverse cerebral venous sinus\n   2. \\>50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography\n   3. Vessel diameter amenable to sizing according to Table 1 below without the need to undersize\n5. Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)\n6. Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up\n7. Life expectancy \\>12 months\n\nExclusion Criteria:\n\n1. 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)\n2. Previously implanted stent in the target vessel\n3. Contraindication to anticoagulant and\u002For antiplatelet therapy or thrombolytic drugs\n4. Target vessel size that does not fall within the indicated range per Table 1 of the IFU\n5. History of severe allergy to contrast\u002Fcontrast media or nickel\n6. Non-pulse-synchronous tinnitus\n7. Current diagnosis of papilledema\n8. Dural arteriovenous fistula or arteriovenous malformation\n9. History of untreated atrial fibrillation, untreated\u002Funcontrollable hypertension, or other stroke factors\n10. History of deep vein thrombosis or pulmonary embolism\n11. History of heart failure, dilated cardiomyopathy, or congenital heart conditions\n12. Arterial stenosis, dissection, or aneurysm\n13. PST due to causes not related to cerebral venous sinus stenosis\n14. Evidence of an active systemic infection\n15. 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.\n16. Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling)\n17. Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis\n18. Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy\n19. Suffered a stroke within the past 6 months\n20. Platelet count \\\u003C100x109\u002FL (100,000\u002FµL)\n21. Participation in another investigational protocol\n22. Immuno-compromised\n23. 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)\n24. Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and\u002For effective procedure\n25. Incapacitated, mentally compromised or otherwise incapable of understanding and\u002For providing informed consent","ALL","18 Years","80 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Pulsatile Tinnitus","Venous Sinus Stenosis","RECRUITING","2026-04-10",{"date":33,"type":34},"2026-04-15","ACTUAL",{"date":36,"type":34},"2026-02-01",{"date":38,"type":22},"2028-07",{"name":40,"class":41},"Sonorous NV, Inc","INDUSTRY",6,""]