Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy (VSSIIH)
Verified December 2012 by Weill Medical College of Cornell University
Information provided by (Responsible Party):
Athos Patsalides MD, Weill Medical College of Cornell University
First received: June 13, 2011
Last updated: December 28, 2012
Last verified: December 2012
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.
Idiopathic Intracranial Hypertension (IIH)
Device: Venous Sinus Stenting
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- Absence of procedure related and device related complications. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Device: Venous Sinus Stenting
Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.
|Ages Eligible for Study:
||21 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01407809
|Weill Cornell Medical College
|New York, New York, United States, 10065 |
|Principal Investigator: Athos Patsalides, MD |
|Sub-Investigator: Pierre Gobin, MD |
|Sub-Investigator: John Tsiouris, MD |
|Sub-Investigator: Marc Dinkin, MD |
Weill Medical College of Cornell University
||Athos Patsalides, MD, MPH
||Weill Medical College of Cornell University
No publications provided
||Athos Patsalides MD, Assistant Professor, Weill Medical College of Cornell University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2011
||December 28, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Central Nervous System Diseases
Nervous System Diseases