BosSTENT implantation for pulse-synchronous tinnitus from venous sinus narrowing

BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus

This trial will try a new stent called BosSTENT to reduce severe pulse-synchronous tinnitus in adults whose symptoms are caused by narrowing of the cerebral venous sinus and improve when the jugular vein is compressed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sonorous NV, Inc (industry)
• Locations: 6 sites (Ottawa, Canada and 5 other locations)
• Trial ID: NCT07070089 on ClinicalTrials.gov

What this trial studies

This is a multicenter interventional study testing the safety and clinical performance of the BosSTENT, a stent designed for transverse cerebral venous sinus stenosis that causes pulse-synchronous tinnitus. Eligible adults with severe tinnitus responsive to jugular compression and imaging-confirmed >50% stenosis will receive BosSTENT implantation and be followed over time. The study will track device-related safety events and changes in tinnitus severity (patient-reported measures and clinical follow-up) as primary outcomes. Enrollment occurs at specialist centers in Canada and France with scheduled clinical and imaging follow-up to monitor both symptom change and vessel patency.

Who should consider this trial

Good fit: Adults 18–80 with severe or catastrophic pulse-synchronous tinnitus that improves with jugular compression, with transverse cerebral venous sinus stenosis >50% on imaging and vessel anatomy suitable for the device are ideal candidates.

Not a fit: Patients whose pulsatile tinnitus is caused by secondary conditions (for example a brain tumor) or whose venous anatomy is not suitable for the stent are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the BosSTENT could meaningfully reduce or eliminate pulse-synchronous tinnitus and improve quality of life for patients with venous sinus stenosis.

How similar studies have performed: Previous case series and smaller studies of venous sinus stenting have reported symptom improvement for pulsatile tinnitus and related conditions, but the BosSTENT represents a device-specific, controlled evaluation.

Eligibility criteria

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

Where this trial is running

Ottawa, Canada and 5 other locations

• The Ottawa Hospital — Ottawa, Canada, Canada (NOT_YET_RECRUITING)
• Unity Health Toronto - St. Michael's Hospital — Toronto, Canada, Canada (NOT_YET_RECRUITING)
• CHU de Bordeaux — Bordeaux, France, France (RECRUITING)
• CHU Montpelier — Montpellier, France, France (RECRUITING)
• Hôpital de la Pitié Salpêtrière — Paris, France, France (NOT_YET_RECRUITING)
• CHRU Tours — Tours, France, France (RECRUITING)

Study contacts

• Study coordinator: James D Nonato, Pharm D

Conditions: Pulsatile Tinnitus, Venous Sinus Stenosis