Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

NCT01407809 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 1004011008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Venous Sinus Stenting

Interventions

Venous Sinus Stenting DEVICE

Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian/ Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 30219791 DERIVED

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Athos Patsalides, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: August 2, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

US (1)