Recruiting

Stenting

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02143258

Conditions

Idiopathic Intracranial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stenting of the venous sinus

Study Details

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.

Conditions

Idiopathic Intracranial Hypertension

Study ID

NCT02143258

Start date

Mar, 2014

Status verified date

May, 2017

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Normalized CSF pressure post venous stenting [ Time Frame: 1,3,6,12 months ]

Central Contacts and Locations

Central contacts

Betty Anne Schwarz, DProf

613-798-5555baschwarz@toh.ca

Locations

The Ottawa Hospital Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Betty Anne Schwarz, DProf

613-798-5555baschwarz@toh.ca

Principal Investigator:

Daniela Iancu, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 15, 2017

Last verified

May, 2017

Keywords

  • stenting venous sinus
  • intracranial hypertension
  • quality of life
  • headache
  • visual impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2017-05-15.