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Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

Sponsored by Weill Medical College of Cornell University

Phase Quota
Phase 1

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.

Study Start Date: January 2012

Estimated Completion Date: June 2017

Specialties: Cardiology: Cardiac Surgery,Hypertension,Vascular Medicine Surgery: Cardiac Surgery Neurology: Headache

Interventions

  • Device: Venous Sinus Stenting
  • Procedure: Venous Sinus Stenting

Inclusion criteria

  • Age > 21 year-old
  • Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders
  • Severe visual function loss, defined as grades 4 and 5 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale
  • Failure of treatment with acetazolamide (Diamox) given at efficient dose (2g/d or maximum tolerated dose). Failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance
  • Failure of treatment with 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
  • 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 criteria

  • Severe allergic reaction to iodine contrast despite pre-medication with steroids
  • Renal function impairment:Creatinine >1.5 mg/dL, and/or Creatinine clearance <60 ml/min
  • Contraindication to general anesthesia
  • Contraindication to aspirin, clopidogrel (Plavix®) or anticoagulants
  • Patients with thrombophilic disorders and anti-cardiolipin syndrome will be excluded from the study. Patients using tetracycline, oral contraceptives or vitamin A, can only be included 3 months after discontinuing these agents
  • Patients with dural arteriovenous fistula (DAVF) or other arteriovenous lesion affecting cortical venous flow will be excluded from the protocol
  • Acute shunt dysfunction in patients with prior CSF diversion procedure
  • Pregnancy or absence of contraception in woman of childbearing potential

Study Locations And Contact Information

  • Weill Cornell Medical College, New York New York

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