BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Incidence of Major adverse events (MAE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BosSTENT
干预措施: BosSTENT implantation (Device)
结局指标
主要结局
Incidence of Major adverse events (MAE)
时间窗: 3 months
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
Improvement of pulse-synchronous tinnitus measured by a decrease of at least 2 grades or 40 points on the Tinnitus Handicap Inventory (THI)
时间窗: 30 days
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)
次要结局
未报告次要终点