Clinical Trial: Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

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 Summary:
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome:

  • Absence of procedure related and device related complications. [ Time Frame: 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. [ Time Frame: 24 months ]
  • Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. [ Time Frame: 24 months ]


Original Primary Outcome:

  • Absence of procedure related and device related complications. [ Time Frame: 24 months ]
  • Clinically significant CSF pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale. [ Time Frame: 24 months ]
  • Greater than 2-bB mean deviation compared to the pre-operative field testing. [ Time Frame: 24 months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Weill Medical College of Cornell University

Dates:
Date Received: June 13, 2011
Date Started: January 2012
Date Completion: June 2019
Last Updated: January 2, 2017
Last Verified: November 2016