Status:
COMPLETED
Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Idiopathic Intracranial Hypertension (IIH)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Age \> 18 years
- Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
- Visual field loss: One of criteria A, B or C must be fulfilled.
- A. Severe visual function loss, defined as grades 4 and 5 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at initial presentation.
- B. Moderate visual function loss, defined as grade 3 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and failure of treatment with acetazolamide (Diamox) given at efficient dose (2g/d or maximum tolerated dose) or Topiramate (Topamax) given at efficient dose (maximum 150mg daily). Failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
- C. Mild visual function loss, defined as grades 0,1 or 2 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and a worsening to moderate or greater visual function loss, defined as grades 3-5, after 1 month of treatment and/or medication intolerance.
- Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
- Signed informed consent obtained from the patient.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01407809
Start Date
January 1 2012
End Date
June 1 2020
Last Update
August 3 2020
Active Locations (1)
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1
New York Presbyterian/ Weill Cornell Medicine
New York, New York, United States, 10065