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

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 Overview

• Status: Completed
• Conditions: Idiopathic Intracranial Hypertension (IIH)
• Intervention / Treatment: Device: Venous Sinus Stenting

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian/ Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Boddu SR, Gobin YP, Dinkin M, Oliveira C, Patsalides A. Impaired drainage of vein of Labbe following venous sinus stenting for idiopathic intracranial hypertension. J Neurointerv Surg. 2019 Mar;11(3):300-306. doi: 10.1136/neurintsurg-2018-014153. Epub 2018 Sep 15.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: 1004011008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes