Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension

NCT02143258 | Unknown DMC

• 1 other identifier: DIancu_IIH
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Normalized CSF pressure post venous stenting

  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.

  1,3,6,12 months

Secondary Outcomes (1)

• Assess the long-term success of this treatment in terms of clinical recurrence rate and long-term patency of the sinus.

  1,3,6,12 months

Other Outcomes (5)

• Assess the effect of stenting in improving visual function in patients with refractory IIH.

  1,3,6,12 months

• Assess the effect of stenting in decreasing headache and its effect on quality of life.

  1,3,6,12 months

• Assess the safety of this treatment in terms of clinical and angiographic complications.

  every 6 months

Study Arms (1)

Neurointerventional

EXPERIMENTAL

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

Interventions

Stenting of the venous sinus PROCEDURE

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.

Also known as: Carotid Wall Stent

Neurointerventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri; Intracranial Hypertension; Headache; Vision Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Eye Diseases

Central Study Contacts

Daniela Iancu, MD

CONTACT

613-798-5555; diancu@toh.ca

Betty Anne Schwarz, DProf

CONTACT

613-798-5555; baschwarz@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: May 21, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

CA (1)