Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy (VSSIIH)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Intracranial Hypertension (IIH)	Device: Venous Sinus Stenting	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
Study Start Date :	January 2012
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2021

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Intervention	Device: Venous Sinus Stenting; Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Outcome Measures

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Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Contacts

Contact: Athos Patsalides, MD MPH	212-746-2821	atp9002@med.cornell.edu
Contact: Marc Dinkin, MD	646-962-4297	mjd2004@med.cornell.edu

Locations

United States, New York
New York Presbyterian/ Weill Cornell Medicine	Recruiting
New York, New York, United States, 10065
Contact: Oscar Lleva, NP 212-746-2821 osl9003@med.cornell.edu
Principal Investigator: Athos Patsalides, MD
Sub-Investigator: Marc Dinkin, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:	Athos Patsalides, MD, MPH	Weill Medical College of Cornell University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Athos Patsalides MD, Associate Professor of Radiology in Neurological Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01407809 History of Changes
Other Study ID Numbers:	1004011008
First Posted:	August 2, 2011
Last Update Posted:	January 17, 2018
Last Verified:	January 2018

Additional relevant MeSH terms:

Hypertension; Intracranial Hypertension; Pseudotumor Cerebri; Vascular Diseases	Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases