BosSTENT implantation for pulse-synchronous tinnitus from venous sinus narrowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Ottawa Hospital
  Ottawa, Canada, Canada Recruiting
• Unity Health Toronto - St. Michael's Hospital
  Toronto, Canada, Canada Recruiting
• CHU de Bordeaux
  Bordeaux, France, France Recruiting
• CHU Montpelier
  Montpellier, France, France Recruiting
• CHRU Tours
  Tours, France, France Recruiting
• Hôpital de la Pitié Salpêtrière
  Paris, France, France Not yet recruiting

Study contacts

• Study coordinator: James D Nonato, Pharm D
• Email: info@sonorousnv.com
• Phone: +1-949-810-0055

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Noninvasive Imaging of Intracranial Venous Sinus Stents with Ultra-High-Resolution Photon-Counting CT Angiography

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• VivaStent: a stent procedure to help pulsatile tinnitus

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• Comparing stent implantation to medical therapy for idiopathic intracranial hypertension

  This study is testing whether putting in a stent helps people with idiopathic intracranial hypertension feel better compared to just using medication.

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• Venous stenting for treating pulsatile tinnitus caused by low-grade dural arteriovenous fistulae

  This study is testing if a new treatment called venous stenting can help people with pulsatile tinnitus caused by certain blood vessel issues feel better compared to standard care.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT05679271

• SiREX stent to treat pulsatile tinnitus from narrowed lateral venous sinus

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• Deep Brain Stimulation for Severe Tinnitus Relief

  This study is testing if deep brain stimulation can help people with severe tinnitus feel better when other treatments haven't worked.

  Recruiting University Hospital, Grenoble · Grenoble · NCT04296097

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.