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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01407809
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 101
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• 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: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Absence of procedure related and device related complications. [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. [24 months]

3. Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

2. 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.

3. 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.

1. 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.

2. Signed informed consent obtained from the patient.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian/ Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01407809
• Other Study ID Numbers: 1004011008
• First Posted: Aug 2, 2011
• Last Update Posted: Aug 3, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Intracranial Hypertension; Pseudotumor Cerebri; Hypertension

Study Results

No Results Posted as of Aug 3, 2020