[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-sinus-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-sinus-stenosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100493614","phase-3-stent-implantation-versus-medical-therapy-for-idiopathic-intracranial-hypertension-simple-100493614","NCT05707442","Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)","Inclusion Criteria:\n\n* Subject Eligibility Criteria\n\n  1. Diagnosis of IIH by modified Dandy criteria about for more than 2 months\n  2. Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment\n  3. Normal cerebrospinal fluid (CSF) composition\n  4. Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI\n  5. Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg\n  6. Patients or their relatives signed written informed consent\n* Ophthalmic Eligibility Criteria:\n\n  1. At least one eye had the presence of papilledema\n  2. At least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15%\n  3. Visual acuity above 20 \u002F 200 (≥ 39 letters)\n\nExclusion Criteria:\n\n* Subject Exclusion Criteria\n\n  1. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting\n  2. Progressive or rapid visual loss needed urgent surgical intervention; if delay\\>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration\n  3. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)\n  4. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure\n  5. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis\n  6. A history of severe thyroid disease and iodine allergy\n  7. Pregnant or lactating women\n  8. Severe cardiopulmonary, liver or kidney failure\n  9. Known hereditary or acquired haemorrhagic diathesis\n  10. Known hereditary or acquired thrombophilia\n  11. Platelet counts or coagulation abnormality\n  12. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days\n  13. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor\n  14. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesia\n  15. Increased intracranial pressure due to other secondary factors\n* Ophthalmic Exclusion Criteria:\n\n  1. Current intraocular pressure \\> 28mmHg or previous intraocular pressure \\> 30mmHg\n  2. Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:\n\n     1. Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and moderate to severe disc tilt); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.\n     2. Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated with hyperopic changes, was at the discretion of the site investigator or reading center leader (or his designee); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.\n  3. Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined by the investigator to be unrelated to vision loss)","60 Years",{"count":51,"type":22},74,[53],"PHASE3","The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.",[56,29],"Idiopathic Intracranial Hypotension",[58,59,60,61,62],"Idiopathic intracranial hypertension","Venous sinus stenosis","Stenting","Medical therapy","Randomized controlled trial","2026-02-08",{"date":65,"type":34},"2026-02-10",{"date":67,"type":34},"2023-02-16",{"date":69,"type":22},"2027-03",{"name":71,"class":72},"Beijing Tiantan Hospital","OTHER",1]