Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension
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|ClinicalTrials.gov Identifier: NCT02143258|
Recruitment Status : Unknown
Verified May 2017 by Ottawa Hospital Research Institute.
Recruitment status was: Recruiting
First Posted : May 21, 2014
Last Update Posted : May 15, 2017
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||Phase|
|Idiopathic Intracranial Hypertension||Procedure: Stenting of the venous sinus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Assess the effect of stenting in improving visual function in patients with refractory IIH. [ Time Frame: 1,3,6,12 months ]
- Assess the effect of stenting in decreasing headache and its effect on quality of life. [ Time Frame: 1,3,6,12 months ]
- Assess the safety of this treatment in terms of clinical and angiographic complications. [ Time Frame: every 6 months ]
- 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 ]
- Assess any improvement or absence of papilledema. [ Time Frame: 1,3,6,12 months ]
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
|Contact: Daniela Iancu, MD||613-798-5555 ext firstname.lastname@example.org|
|Contact: Betty Anne Schwarz, DProf||613-798-5555 ext email@example.com|
|The Ottawa Hospital Civic Campus||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Daniela Iancu, MD 613-798-5555 ext 78571 firstname.lastname@example.org|
|Contact: Betty Anne Schwarz, DProf 613-798-5555 ext 17522 email@example.com|
|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|