Venous StEnt for Idiopathic IntraCranial HypertEnsion (VEHICLE) Registry: Management and Outcomes in the MENA Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Symptom Improvement
研究概览
简要总结
The VEHICLE Registry is a multicenter observational study aimed at evaluating the management and outcomes of patients with Idiopathic Intracranial Hypertension (IIH) undergoing venous sinus stenting in the Middle East and North Africa (MENA) region. The study focuses on assessing clinical characteristics, treatment efficacy, safety, and the role of venous sinus stenting as a therapeutic modality in IIH.
详细描述
Idiopathic Intracranial Hypertension (IIH) is a condition characterized by elevated intracranial pressure without an identifiable cause, leading to symptoms such as headaches, visual disturbances, and potential vision loss due to papilledema. The condition predominantly affects obese women of childbearing age and is associated with risk factors like obesity, recent weight gain, hypothyroidism, and polycystic ovary syndrome (PCOS).
Venous sinus stenosis has been implicated in the pathophysiology of IIH. Venous sinus stenting has emerged as a promising treatment option for patients who are refractory to medical therapy or intolerant to medications like acetazolamide.
The VEHICLE Registry collects real-world data from multiple centers in the MENA region to evaluate the efficacy and safety of venous sinus stenting in patients with IIH. The registry analyzes patient demographics, clinical presentations, imaging findings, treatment details, and outcomes over a six-month follow-up period to improve understanding and management of IIH in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Diagnosed with Idiopathic Intracranial Hypertension (IIH) based on the modified Dandy criteria, including:
- •Symptoms of increased intracranial pressure (e.g., headache, visual disturbances).
- •Elevated opening pressure (>250 mm H₂O) on lumbar puncture with normal cerebrospinal fluid composition.
- •No evidence of intracranial pathology (e.g., mass lesion, hydrocephalus) on neuroimaging.
- •Presence of papilledema. Evidence of venous sinus stenosis on Magnetic Resonance Venography (MRV) or Digital Subtraction Angiography (DSA).
- •Refractory to medical therapy or intolerant to medications (e.g., acetazolamide).
- •Willingness to undergo venous sinus stenting. Provided informed consent for participation.
排除标准
- •Secondary causes of intracranial hypertension (e.g., cerebral venous sinus thrombosis, neoplasm).
- •Coagulopathies or contraindications to antiplatelet or anticoagulation therapy. Pregnancy or lactation. Incomplete baseline data or inability to complete follow-up assessments. Severe comorbid conditions that preclude endovascular procedures.
结局指标
主要结局
Symptom Improvement
时间窗: Six months post-procedure.
Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting.
Change in Papilledema Grade
时间窗: Six months post-procedure.
Improvement in papilledema grade assessed by fundoscopic examination using the Frisén scale from baseline to six months post-procedure.
Quality of Life Improvement
时间窗: Baseline and six months post-procedure.
Change in Quality of Life (QOL) scores measured using a standardized questionnaire from baseline to six months post-procedure.
次要结局
- Stent Patency Rate(Six months post-procedure.)
- Adverse Events(Up to six months post-procedure.)
- Cranial Neuropathy Resolution(Six months post-procedure.)
- Visual Field Improvement(Six months post-procedure.)
研究者
Ossama Mansour
Professor of Neurology and stroke
Middle East North Africa Stroke and Interventional Neurotherapies Organization