Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
- Conditions
- Idiopathic Intracranial Hypertension (IIH)
- Interventions
- Device: Venous Sinus Stenting
- Registration Number
- NCT01407809
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Venous Sinus Stenting -
- Primary Outcome Measures
Name Time Method Absence of procedure related and device related complications. 24 months Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. 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. 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York Presbyterian/ Weill Cornell Medicine
🇺🇸New York, New York, United States