Идёт набор NCT07070089

BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus

Без фазы С лечением Pulsatile Tinnitus Venous Sinus Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: BosSTENT implantation.
Кому может быть актуально: Состояния в реестре: Pulsatile Tinnitus, Venous Sinus Stenosis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада, Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus

Обзор

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.

Вмешательства

Устройство BosSTENT implantation
BosSTENT implantation in the transverse venous sinus

Первичные конечные точки

Incidence of Major adverse events (MAE) [Срок оценки: 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) [Срок оценки: 30 days]

Критерии участия

Критерии включения

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

Критерии исключения

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