Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

NCT ID: NCT01407809

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2020-06-01

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Venous Sinus Stenting

Intervention Type: DEVICE

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

Interventions

Venous Sinus Stenting

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athos Patsalides, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian/ Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30219791 (View on PubMed)

Other Identifiers

1004011008

Identifier Type: -

Identifier Source: org_study_id