BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus
Canada, France90 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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)
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
What they're measuring
1
Incidence of Major adverse events (MAE)
Timeframe: 3 months
2
Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI)