NCT01407809

Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Interventions

Type	Name	Description
DEVICE	Venous Sinus Stenting	Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Timeline

• Start date: 2012-01-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2011-08-02
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study