Idiopathic Intracranial HypertensionNCT02143258
Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension
A study testing Stenting of the venous sinus in people with Idiopathic Intracranial Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Stenting of the venous sinus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9
Daniela Iancu, MD, 613-798-5555 ext. 78571, diancu@toh.ca
Betty Anne Schwarz, DProf, 613-798-5555 ext. 17522, baschwarz@toh.ca
About this study
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.
Read the detailed description
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 not be blinded to any of the study procedures or study materials used in this trial.
Patients who undergo stenting of their venous system will have venous pressure measurements taken. If the degree of stenosis is more than 50% with a difference in pressure in the CSF of more than 8 mmHg, the patient will be stented.
Venous pressure measurements and transverse sinus stenting First step: Venous pressure measurements Once the patient is under local anesthesia, femoral venous puncture for cerebral venogram will be performed. Once femoral venous access has been obtained, catheterization of the right or left jugular vein is performed. Microcatheterization of the sinus and venous pressure measurements distal and proximal to the stenosis are done.
Second step: Procedure In preparation for stent, patients will receive Aspirin 81mg daily and Clopidogrel (Plavix ®) 75 mg daily for 4 days prior to the intervention.
On the day of the procedure, the patient will receive a general anesthesia plus a bolus of heparin (70UI/Kg).
Endovascular Intervention:
A venous femoral puncture will be completed to allow for a 6-8 French long sheath placement followed by retrograde catheterization of the right or left jugular vein.
Deployment of the stent across the stenosis with or without venous angioplasty will be done. Hemostasis with manual compression is completed at the end of the procedure.
After the procedure the patients are admitted overnight for monitoring (on neurosurgery unit). Patients will be discharged home 24 hours after the procedure and will continue Aspirin and Clopidogrel (Plavix®) 75mg every day x 3 month then aspirin only.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Stenting of the venous sinus
- Keywords
- stenting venous sinus, intracranial hypertension, quality of life, headache, visual impairment
- Medical subject headings
- Pseudotumor Cerebri, Intracranial Hypertension, Headache, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of the venous sinusProcedure or surgery
Also called Carotid Wall Stent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stenting of the venous sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143258
- Sponsor's protocol ID
- DIancu_IIH
- Status last verified
- May 2017
- First submitted
- 4 Mar 2014
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT02143258
- Acronym / sponsor ID
- DIancu_IIH
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- stenting venous sinus, intracranial hypertension, quality of life, headache, visual impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 not be blinded to any of the study procedures or study materials used in this trial.
Patients who undergo stenting of their venous system will have venous pressure measurements taken. If the degree of stenosis is more than 50% with a difference in pressure in the CSF of more than 8 mmHg, the patient will be stented.
Venous pressure measurements and transverse sinus stenting First step: Venous pressure measurements Once the patient is under local anesthesia, femoral venous puncture for cerebral venogram will be performed. Once femoral venous access has been obtained, catheterization of the right or left jugular vein is performed. Microcatheterization of the sinus and venous pressure measurements distal and proximal to the stenosis are done.
Second step: Procedure In preparation for stent, patients will receive Aspirin 81mg daily and Clopidogrel (Plavix ®) 75 mg daily for 4 days prior to the intervention.
On the day of the procedure, the patient will receive a general anesthesia plus a bolus of heparin (70UI/Kg).
Endovascular Intervention:
A venous femoral puncture will be completed to allow for a 6-8 French long sheath placement followed by retrograde catheterization of the right or left jugular vein.
Deployment of the stent across the stenosis with or without venous angioplasty will be done. Hemostasis with manual compression is completed at the end of the procedure.
After the procedure the patients are admitted overnight for monitoring (on neurosurgery unit). Patients will be discharged home 24 hours after the procedure and will continue Aspirin and Clopidogrel (Plavix®) 75mg every day x 3 month then aspirin only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurointerventional | Experimental | Procedure: Stenting of the venous sinusStenting 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stenting of the venous sinusAlso: Carotid Wall StentPatients 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. | Procedure or surgery | Neurointerventional |
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.
1 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting of the venous sinus in people with Idiopathic Intracranial Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Iancu, MD (613-798-5555 ext. 17314, diancu@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalized CSF pressure post venous stenting (time frame: 1,3,6,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.