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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01407809
Other study ID # 1004011008
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2012
Est. completion date June 1, 2020

Study information

Verified date July 2020
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Venous Sinus Stenting
Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

Locations

Country Name City State
United States New York Presbyterian/ Weill Cornell Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absence of procedure related and device related complications. 24 months
Primary 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
Primary Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. 24 months
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