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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
BosSTENT implantation in the transverse venous sinus
The Ottawa Hospital
Ottawa, Canada, Canada
NOT_YET_RECRUITINGUnity Health Toronto - St. Michael's Hospital
Toronto, Canada, Canada
NOT_YET_RECRUITINGCHU de Bordeaux
Bordeaux, France, France
RECRUITINGIncidence of Major adverse events (MAE)
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
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)
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)
Time frame: 30 days
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CHU Montpelier
Montpellier, France, France
RECRUITINGHôpital de la Pitié Salpêtrière
Paris, France, France
NOT_YET_RECRUITINGCHRU Tours
Tours, France, France
RECRUITING