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临床试验/NCT01407809
NCT01407809已完成1 期

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Absence of procedure related and device related complications.

研究概览

简要总结

Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Absence of procedure related and device related complications.

时间窗: 24 months

Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing.

时间窗: 24 months

Clinically significant cerebrospinal fluid (CSF) pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale.

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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