Pulsatile Tinnitus, Venous Sinus Stenosis
Conditions
Brief summary
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.
Interventions
DEVICEBosSTENT implantation
BosSTENT implantation in the transverse venous sinus
Sponsors
Sonorous NV, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥18 - 80 years old 2. Able to provide informed consent to participate in the study 3. Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression. 4. Cerebral venous sinus stenosis with the following characteristics: 1. Transverse cerebral venous sinus 2. \>50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography 3. Vessel diameter amenable to sizing according to Table 1 below without the need to undersize 5. Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy) 6. Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up 7. Life expectancy \>12 months
Exclusion criteria
1. 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) 2. Previously implanted stent in the target vessel 3. Contraindication to anticoagulant and/or antiplatelet therapy or thrombolytic drugs 4. Target vessel size that does not fall within the indicated range per Table 1 of the IFU 5. History of severe allergy to contrast/contrast media or nickel 6. Non-pulse-synchronous tinnitus 7. Current diagnosis of papilledema 8. Dural arteriovenous fistula or arteriovenous malformation 9. History of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke factors 10. History of deep vein thrombosis or pulmonary embolism 11. History of heart failure, dilated cardiomyopathy, or congenital heart conditions 12. Arterial stenosis, dissection, or aneurysm 13. PST due to causes not related to cerebral venous sinus stenosis 14. Evidence of an active systemic infection 15. 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. 16. Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling) 17. Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis 18. Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy 19. Suffered a stroke within the past 6 months 20. Platelet count \<100x109/L (100,000/µL) 21. Participation in another investigational protocol 22. Immuno-compromised 23. 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) 24. Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and/or effective procedure 25. Incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major adverse events (MAE) | 3 months | MAEs are defined as symptomatic, serious, procedure- or device-related post-procedure complications: major stroke, neurological death, in-stent thrombosis, target vessel restenosis, stent-adjacent stenosis, or stent migration |
| Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI) | 30 days | THI ranges from 0-100 points with zero indicating no handicap due to tinnitus and increasing scores indicating progressively worse handicap due to tinnitus. Grades range from 1-5 going from Slight (0-16 points), to Mild (18-36 points), Moderate (38-56 points), Severe (58-76 points) and finally Catastrophic (78-100 points) |
Countries
Canada, France
Contacts
CONTACTJames D Nonato, Pharm D
Outcome results
None listed