Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/26/2019 |
| Start Date: | January 2012 |
| End Date: | June 2021 |
| Contact: | Athos Patsalides, MD MPH |
| Email: | atp9002@med.cornell.edu |
| Phone: | 212-746-2821 |
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.
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.
INCLUSION CRITERIA
1. Age > 18 years
2. Established diagnosis of Idiopathic Intracranial Hypertension according to the
criteria of the 2004 International Classification of Headache Disorders (Table 3).
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.
4. 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.
5. Signed informed consent obtained from the patient.
We found this trial at
1
site
425 East 61st Street
New York, New York 10065
New York, New York 10065
Principal Investigator: Athos Patsalides, MD
Phone: 212-746-2821
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