Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Acandis GmbH
- 入组人数
- 99
- 主要终点
- Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up
研究概览
简要总结
The objective of this clinical investigation is to evaluate and demonstrate the clinical benefit, performance, and safety of the SILANCE Stent, which is specifically designed for the treatment of patients with symptomatic sinus stenoses associated with IIH.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modified Dandy Criteria.
- •Cerebrospinal fluid (CSF) lumbar puncture opening pressure > 25 cm H₂O.
- •Presence of lateral venous sinus stenosis confirmed by venous magnetic resonance angiography (MRA) or venous computed tomography angiography (CTA).
- •Presence of clinical symptoms consistent with IIH, including headaches, visual field loss, papilledema or pulsatile tinnitus.
- •Venous pressure gradient across the stenosis > 3 mmHg under general anaesthesia, > 4 mmHg under local anaesthesia.
- •Temporal Bone CT done for Patients suffering from Pulsatile Tinnitus
- •Written informed consent obtained prior to any study-related procedures.
排除标准
- 未提供
研究组 & 干预措施
Implantation of SILANCE Stent / Elimination of the lateral sinus stenosis
干预措施: SILANCE Stent Implantation (Device)
结局指标
主要结局
Rate of patients with disappearance or significant improvement of IIH related symptoms at first follow-up
时间窗: 6 months
The disappearance or significant improvement of symptoms related to venous sinus stenosis at the first follow-up (6 months) will be evaluated as follows: 1 Headaches will be assessed using the Headache Impact Test (HIT-6). The scale consists of six items with five-point response options and yields a total score ranging from 36 to 78, with higher scores indicating greater headache-related impairment. 2\. Pulsatile tinnitus will be assessed using the Tinnitus Functional Index (TFI). The Tinnitus Functional Index (TFI) is a validated 25-item patient-reported measure of tinnitus severity across eight domains, yielding a total score from 0 to 100 (higher scores indicating greater severity). 3\. Visual impairment will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25).It consists of 25 items across multiple subscales and provides subscale as well as an overall score ranging from 0 to 100, where higher scores indicate better vision-related quality.
Number of patients with disappearance or a clinically significant reduction of the transstenotic venous pressure gradient following implantation of the SILENCE stent.
时间窗: Periprocedural
Venous pressure is measured at at least two locations: proximal (upstream) to the stenosis at the torcular Herophili and distal (downstream) to the stenosis at the jugular bulb. Only patients demonstrating a venous pressure gradient of \> 3 mmHg under general anesthesia and \> 4 mmHg under local anesthesia are eligible for inclusion in the study. The pressure gradient is assessed both before and after stent implantation. A reduction in the pressure gradient is considered indicative of achieving the efficacy endpoint.
Rate of major adverse events at 6 months (± 3) months and 12 (±3) months
时间窗: 6 months and 12 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.
次要结局
未报告次要终点