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

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 by Weill Medical College of Cornell University

Sponsor:

Information provided by (Responsible Party):

Athos Patsalides MD, Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT01407809

First received: June 13, 2011

Last updated: January 16, 2016

Last verified: January 2016

History of Changes

Purpose

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	Intervention	Phase
Idiopathic Intracranial Hypertension (IIH)	Device: Venous Sinus Stenting	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Pseudotumor Cerebri

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

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:	20
Study Start Date:	January 2012
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intervention	Device: Venous Sinus Stenting Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Eligibility


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

Criteria

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).
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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407809

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
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10065
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


Responsible Party:	Athos Patsalides MD, Assistant Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01407809 History of Changes
Other Study ID Numbers:	1004011008
Study First Received:	June 13, 2011
Last Updated:	January 16, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 30, 2016

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