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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Athos Patsalides MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01407809
First received: June 13, 2011
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Idiopathic Intracranial Hypertension (IIH)
Device: Venous Sinus Stenting
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Absence of procedure related and device related complications. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Device: Venous Sinus Stenting
Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 21 year-old
  • Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders
  • Severe visual function loss, defined as grades 4 and 5 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale
  • Failure of treatment with acetazolamide (Diamox) given at efficient dose (2g/d or maximum tolerated dose). Failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
  • Failure of treatment with 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.
  • 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.

Exclusion Criteria:

  • Severe allergic reaction to iodine contrast despite pre-medication with steroids.
  • Renal function impairment:Creatinine >1.5 mg/dL, and/or Creatinine clearance <60 ml/min
  • Contraindication to general anesthesia.
  • Contraindication to aspirin, clopidogrel (Plavix®) or anticoagulants.
  • Patients with thrombophilic disorders and anti-cardiolipin syndrome will be excluded from the study. Patients using tetracycline, oral contraceptives or vitamin A, can only be included 3 months after discontinuing these agents.
  • Patients with dural arteriovenous fistula (DAVF) or other arteriovenous lesion affecting cortical venous flow will be excluded from the protocol.
  • Acute shunt dysfunction in patients with prior CSF diversion procedure.
  • Pregnancy or absence of contraception in woman of childbearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407809

Contacts
Contact: Athos Patsalides, MD, MPH 212-746-2821 atp9002@med.cornell.edu
Contact: Marc Dinkin, MD 646-962-4297 mjd2004@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Principal Investigator: Athos Patsalides, MD         
Sub-Investigator: Pierre Gobin, MD         
Sub-Investigator: John Tsiouris, MD         
Sub-Investigator: Marc Dinkin, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Athos Patsalides, MD, MPH Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Athos Patsalides MD, Assistant Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01407809     History of Changes
Other Study ID Numbers: 1004011008
Study First Received: June 13, 2011
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Pseudotumor Cerebri
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014