Clinical Trial: Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension

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.


Detailed Summary:

Despite the fact that the results of venous stenting in IIH are still preliminary, it suggests that this technique could become a viable alternative for medically refractory IIH patients with transverse sinus stenosis. However, prospective studies with long-term, standardized and independent follow-up are required to evaluate this new alternative with a higher level of evidence.

Normalization of CSF pressure will be present after venous sinus stenting at 6 months in more than 70% of patients in a cohort of medically refractory IIH patients. (Refractory IIH is defined as absence of improvement in papilledema, visual function or headache after three months of medical treatment or intolerance to the medical regimen).

A complementary hypothesis is that the mean decrease in CSF pressure post stenting will be equal or more than 15 mmHg.

The proposed research is a prospective cohort study that will be aimed to assess the efficacy of venous stenting by normalizing CSF pressure and improving symptoms of quality of life in patients with medically refractory IIH. Concomitantly; it will also estimate its recurrence and complications rate.

The study will be conducted locally at The Ottawa Hospital with an aim of enrolling 33 patients into the trial.

Interventions The goal of this study is to assess the overall efficacy of venous stenting to normalize patients CSF pressure with little or no risk. The premise of the study is that opening the venous sinus will reduce the patient's intracranial pressure and improve their visual capabilities. Therefore; the aim of treatment is to improve the patient's overall symptomology related to IIH. The interventionalist and the interventional team can no
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: March 4, 2014
Date Started: March 2014
Date Completion: July 2017
Last Updated: May 11, 2017
Last Verified: May 2017