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Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension

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ClinicalTrials.gov Identifier: NCT02143258
Recruitment Status : Recruiting
First Posted : May 21, 2014
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Increased Intracranial Hypertension (IIH), also known as Pseudotumor Cerebri, is defined by increased cerebral spinal fluid (CSF) pressure in the absence of intracranial, metabolic, toxic or hormonal causes of intracranial hypertension. It is characterized by headaches, tinnitus and visual loss, due to optic atrophy, in 50% of cases. Surgical treatments, such as CSF shunt placement and optic nerve sheath fenestration (ONSF), are indicated in case of failure or non-compliance (owing to side effects) of medical treatments (that mainly includes weight loss and drugs, such as Carbonic Anhydrase Inhibitors). However, these surgical treatments are limited by relative high complications and recurrence rate. Indeed, improvement in visual function after ONSF is often transient and the risk of complications, including visual loss, pupillary dysfunction, and vascular complications is up to 40%. With no better treatment option, intraventricular or lumbar shunt placement has become the traditional treatment for medically refractory IIH, despite poor results. Indeed, series of patients with IIH treated with shunt replacement report a complications rate (shunt occlusion, disconnection, infection or intracranial hematoma formation) around 50% and a failure rate up to 64% within 6 months. As a consequence, shunt revision is often required and efficacy of the technique to control the disease is questionable.

The role of intracranial transverse sinus stenosis in IIH has recently gained a particular interest. Despite the fact that transverse sinus stenosis in IIH may be due to increased intracranial pressure, some authors believe that the rise in intracranial pressure and its effect are worsened by the secondary appearance of the venous sinus stenosis. To date, very few complications have been reported in IIH patients with venous sinus stent placement.


Condition or disease Intervention/treatment
Idiopathic Intracranial Hypertension Procedure: Stenting of the venous sinus

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension
Study Start Date : March 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Neurointerventional
Stenting of the venous sinus is the neuro-interventional treatment that is being offered to patients with idiopathic intracranial hypertension that are refractory to medical management.
Procedure: Stenting of the venous sinus
Patients with medically refractory idiopathic intracranial hypertension who meet the eligibility criteria will be offered stenting of their venous sinus in effort to reduce their intracranial pressure and improve their visual capabilities.
Other Name: Carotid Wall Stent


Outcome Measures

Primary Outcome Measures :
  1. Normalized CSF pressure post venous stenting [ Time Frame: 1,3,6,12 months ]
    The primary outcome will be normalization of CSF pressure after venous stenting at 6 months in more than 70% of the patients in a cohort of medically refractory IHH (idiopathic intracranial hypertension) patients.


Secondary Outcome Measures :
  1. Assess the long-term success of this treatment in terms of clinical recurrence rate and long-term patency of the sinus. [ Time Frame: 1,3,6,12 months ]
    The secondary outcomes will consist of safety data (number of adverse events and severity of adverse events. Morbidity and mortality will be considered as secondary endpoints. A morbid event will be defined as an adverse event of any severity being possibly and probably related to the disease or the treatments and happening during the twelve-month follow-up period.


Other Outcome Measures:
  1. Assess the effect of stenting in improving visual function in patients with refractory IIH. [ Time Frame: 1,3,6,12 months ]
  2. Assess the effect of stenting in decreasing headache and its effect on quality of life. [ Time Frame: 1,3,6,12 months ]
  3. Assess the safety of this treatment in terms of clinical and angiographic complications. [ Time Frame: every 6 months ]
  4. Assess the long-term success of this treatment in terms of clinical recurrence rate and long-term patency of the sinus. [ Time Frame: 1,3,6,12 months ]
  5. Assess any improvement or absence of papilledema. [ Time Frame: 1,3,6,12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 year-old, living in Ontario, Canada
  • Patient with diagnostic of Idiopathic Intracranial Hypertension, who failed medical treatment.
  • Venous imaging showing bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus atresia.
  • Pressure gradient across the stenosis > 8 mmHg
  • Signed informed consent obtained from the patient

Exclusion Criteria:

  • Allergic reaction to iodine contrast despite premedication
  • Contraindication to general anesthesia,
  • Contraindication to Aspirin, Clopidogrel (Plavix®) or anticoagulants
  • Patient with medical history of intracranial venous thrombosis
  • Pregnant women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143258


Contacts
Contact: Daniela Iancu, MD 613-798-5555 ext 17314 diancu@toh.ca
Contact: Betty Anne Schwarz, DProf 613-798-5555 ext 17522 baschwarz@toh.ca

Locations
Canada, Ontario
The Ottawa Hospital Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Daniela Iancu, MD    613-798-5555 ext 78571    diancu@toh.ca   
Contact: Betty Anne Schwarz, DProf    613-798-5555 ext 17522    baschwarz@toh.ca   
Principal Investigator: Daniela Iancu, MD         
Sub-Investigator: Lucian Sitwell, MD         
Sub-Investigator: Zackon David, MD         
Sub-Investigator: Danah AlBreiki, MD         
Sub-Investigator: Betty Anne Schwarz, DProf         
Sub-Investigator: Carlos Torres, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02143258     History of Changes
Other Study ID Numbers: DIancu_IIH
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Ottawa Hospital Research Institute:
stenting venous sinus
intracranial hypertension
quality of life
headache
visual impairment

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