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Recruiting NCT07070089

BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus

No phase Interventional Pulsatile Tinnitus Venous Sinus Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BosSTENT implantation.
Who it may be relevant to
Registry conditions: Pulsatile Tinnitus, Venous Sinus Stenosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus

Overview

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

  • Device BosSTENT implantation
    BosSTENT implantation in the transverse venous sinus

Primary outcome measures

  • Incidence of Major adverse events (MAE) [Time frame: 3 months]
  • Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI) [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Male or female ≥18 - 80 years old
  • Able to provide informed consent to participate in the study
  • Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.
  • Cerebral venous sinus stenosis with the following characteristics:
  • Transverse cerebral venous sinus
  • >50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography
  • Vessel diameter amenable to sizing according to Table 1 below without the need to undersize
  • Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)
  • Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up
  • Life expectancy >12 months

Exclusion criteria

  • 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)
  • Previously implanted stent in the target vessel
  • Contraindication to anticoagulant and/or antiplatelet therapy or thrombolytic drugs
  • Target vessel size that does not fall within the indicated range per Table 1 of the IFU
  • History of severe allergy to contrast/contrast media or nickel
  • Non-pulse-synchronous tinnitus
  • Current diagnosis of papilledema
  • Dural arteriovenous fistula or arteriovenous malformation
  • History of untreated atrial fibrillation, untreated/uncontrollable hypertension, or other stroke factors
  • History of deep vein thrombosis or pulmonary embolism
  • History of heart failure, dilated cardiomyopathy, or congenital heart conditions
  • Arterial stenosis, dissection, or aneurysm
  • PST due to causes not related to cerebral venous sinus stenosis
  • Evidence of an active systemic infection
  • 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.
  • Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling)
  • Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis
  • Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy
  • Suffered a stroke within the past 6 months
  • Platelet count <100x109/L (100,000/µL)
  • Participation in another investigational protocol
  • Immuno-compromised
  • 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)
  • Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and/or effective procedure
  • Incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 4 centers
  • CHU de Bordeaux — Bordeaux
  • CHU Montpelier — Montpellier
  • Hôpital de la Pitié Salpêtrière — Paris
  • CHRU Tours — Tours
Canada · 2 centers
  • The Ottawa Hospital — Ottawa
  • Unity Health Toronto - St. Michael's Hospital — Toronto

Identifiers

NCT: NCT07070089 · CIP-001SON

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗