Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Normalized CSF pressure post venous stenting
研究概览
简要总结
Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic, toxic or hormonal causes of intracranial hypertension. It is characterized by headaches, tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such as CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of failure or non-compliance (owing to side effects) of medical treatments (that mainly includes weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these surgical treatments are limited by relative high complications and recurrence rate. Indeed, improvement in visual function after ONSF is often transient and the risk of complications, including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With no better treatment option, intraventricular or lumbar shunt placement has become the traditional treatment for medically refractory IIH, despite poor results. Indeed, series of patients with IIH treated with shunt replacement report a complications rate (shunt occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a failure rate up to 64% within 6 months. As a consequence, shunt revision is often required and efficacy of the technique to control the disease is questionable.
The role of intracranial transverse sinus stenosis in IIH has recently gained a particular interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased intracranial pressure, some authors believe that the rise in intracranial pressure and its effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very few complications have been reported in IIH patients with venous sinus stent placement.
详细描述
Despite the fact that the results of venous stenting in IIH are still preliminary, it suggests that this technique could become a viable alternative for medically refractory IIH patients with transverse sinus stenosis. However, prospective studies with long-term, standardized and independent follow-up are required to evaluate this new alternative with a higher level of evidence.
Normalization of CSF pressure will be present after venous sinus stenting at 6 months in more than 70% of patients in a cohort of medically refractory IIH patients. (Refractory IIH is defined as absence of improvement in papilledema, visual function or headache after three months of medical treatment or intolerance to the medical regimen).
A complementary hypothesis is that the mean decrease in CSF pressure post stenting will be equal or more than 15 mmHg.
The proposed research is a prospective cohort study that will be aimed to assess the efficacy of venous stenting by normalizing CSF pressure and improving symptoms of quality of life in patients with medically refractory IIH. Concomitantly; it will also estimate its recurrence and complications rate.
The study will be conducted locally at The Ottawa Hospital with an aim of enrolling 33 patients into the trial.
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
- •Age > 18 year-old, living in Ontario, Canada
- •Patient with diagnostic of Idiopathic Intracranial Hypertension, who failed medical treatment.
- •Venous imaging showing bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus atresia.
- •Pressure gradient across the stenosis > 8 mmHg
- •Signed informed consent obtained from the patient
排除标准
- •Allergic reaction to iodine contrast despite premedication
- •Contraindication to general anesthesia,
- •Contraindication to Aspirin, Clopidogrel (Plavix®) or anticoagulants
- •Patient with medical history of intracranial venous thrombosis
- •Pregnant women
结局指标
主要结局
Normalized CSF pressure post venous stenting
时间窗: 1,3,6,12 months
The primary outcome will be normalization of CSF pressure after venous stenting at 6 months in more than 70% of the patients in a cohort of medically refractory IHH (idiopathic intracranial hypertension) patients.
次要结局
- Assess the long-term success of this treatment in terms of clinical recurrence rate and long-term patency of the sinus.(1,3,6,12 months)
