Idiopathic Intracranial Hypertension (IIH)Phase 1VSSIIHNCT01407809
Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
A Phase 1 study testing Venous Sinus Stenting in people with Idiopathic Intracranial Hypertension (IIH), run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Venous Sinus Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 1 Jun 2020
- Phase
- Phase 1
- 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 years
- Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
- Visual field loss: One of criteria A, B or C must be fulfilled.
- Severe visual function loss, defined as grades 4 and 5 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at initial presentation.
- Moderate visual function loss, defined as grade 3 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and failure of treatment with acetazolamide (Diamox) given at efficient dose (2g/d or maximum tolerated dose) or Topiramate (Topamax) given at efficient dose (maximum 150mg daily). Failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.
- Mild visual function loss, defined as grades 0,1 or 2 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and a worsening to moderate or greater visual function loss, defined as grades 3-5, after 1 month of treatment and/or medication intolerance.
- Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
- Signed informed consent obtained from the patient.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian/ Weill Cornell Medicine
New York, New York, 10065
About this study
Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.
- Being tested
- Venous Sinus Stenting
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Sinus StentingDevice
Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Venous Sinus Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of procedure related and device related complications.
Measured: 24 months
Clinically significant cerebrospinal fluid (CSF) pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale.
Measured: 24 months
Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJan 2012
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athos Patsalides, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407809
- Sponsor's protocol ID
- 1004011008
- Acronym
- VSSIIH
- Status last verified
- Jul 2020
- First submitted
- 13 Jun 2011
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Boddu SR, Gobin YP, Dinkin M, Oliveira C, Patsalides A. Impaired drainage of vein of Labbe following venous sinus stenting for idiopathic intracranial hypertension. J Neurointerv Surg. 2019 Mar;11(3):300-306. doi: 10.1136/neurintsurg-2018-014153. Epub 2018 Sep 15.
PubMed 30219791
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy
- ClinicalTrials.gov ID
- NCT01407809
- Acronym / sponsor ID
- VSSIIH / 1004011008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 2 Aug 2011 (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.
Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Venous Sinus Stenting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
- Visual field loss: One of criteria A, B or C must be fulfilled.
- Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
- Signed informed consent obtained from the patient.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Venous Sinus StentingVenous sinus stenting consists of placing a stent into the narrowed veins of the brain. | Device | Intervention |
Primary outcome
Absence of procedure related and device related complications.
Time frame: 24 months
Clinically significant cerebrospinal fluid (CSF) pressure reduction AND improvement of more than one grade in the Humphrey Field SITA Standard 24-2 Test grading scale.
Time frame: 24 months
Greater than 2 decibel (dB) mean deviation compared to the pre-operative field testing.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 30219791Boddu SR, Gobin YP, Dinkin M, Oliveira C, Patsalides A. Impaired drainage of vein of Labbe following venous sinus stenting for idiopathic intracranial hypertension. J Neurointerv Surg. 2019 Mar;11(3):300-306. doi: 10.1136/neurintsurg-2018-014153. Epub 2018 Sep 15.
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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.
Athos Patsalides, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venous Sinus Stenting in people with Idiopathic Intracranial Hypertension (IIH), run by Weill Medical College of Cornell University at 1 site in United States.
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 8 inclusion and 0 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: finished, as of the sponsor's last update on 3 Aug 2020. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of procedure related and device related complications. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407809, which also lists 1 linked publication.
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 3 Aug 2020.