Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy (VSSIIH)
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ClinicalTrials.gov Identifier: NCT01407809 |
Recruitment Status
:
Recruiting
First Posted
: August 2, 2011
Last Update Posted
: January 17, 2018
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Condition or disease | Intervention/treatment | Phase |
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Idiopathic Intracranial Hypertension (IIH) | Device: Venous Sinus Stenting | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention |
Device: Venous Sinus Stenting
Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.
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- Absence of procedure related and device related complications. [ Time Frame: 24 months ]
- 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 ]
- Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. [ Time Frame: 24 months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407809
Contact: Athos Patsalides, MD MPH | 212-746-2821 | atp9002@med.cornell.edu | |
Contact: Marc Dinkin, MD | 646-962-4297 | mjd2004@med.cornell.edu |
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 |
Principal Investigator: | Athos Patsalides, MD, MPH | Weill Medical College of Cornell University |
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 Key Record Dates |
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 |