Idiopathic Intracranial HypertensionNCT03556085
Venous Sinus Stenting With the River Stent in IIH
A study testing Venous sinus stenting (Serenity River) in people with Idiopathic Intracranial Hypertension, run by Serenity Medical, Inc. at 6 sites in United States.
Trial summary
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- Venous sinus stenting (Serenity River)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Aug 2018to 1 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for participation in the study:
- Subject is > 18 year-old and has given informed consent.
- Diagnosis of IIH per Modified Dandy Criteria.
- CSF opening pressure is > 25 cm H2O.
- Radiological examination (magnetic resonance venography (MRV) or computed tomographic venography (CTV)) shows bilateral transverse-sigmoid venous sinus stenosis (> 50%) or unilateral stenosis of the dominant sinus with contralateral hypoplastic sinus.
- Presence of IIH clinical symptoms (6. OR 7.)
Show all 11Show fewer
- Headaches: Score > 59 (severe impact) on the HIT-6 scale, refractory to medical therapy (e.g. acetazolamide 1000 mg twice daily, topiramate 100 mg twice daily, or other headache medication) for ≥ 4 weeks, or treatment intolerance OR
- Visual field loss: defined by perimetric mean deviation (PMD) between -6 dB and -30 dB in one or both eyes (with papilledema Grade >1) despite at least 2 weeks of medical therapy with acetazolamide 1000 mg twice daily, or if the visual field deteriorates by more than 2 dB during treatment, or treatment intolerance.
- In the absence of this study, the subject would have been offered a surgical intervention by Optic Nerve Sheath Fenestration (ONSF), Cerebro Spinal Fluid (CSF) shunting procedure, or venous sinus stenting with an off-label device.
- Catheter manometry shows a pressure gradient > 8 mm Hg across the transverse sigmoid sinus stenosis.
- Venographic evidence of sinus stenosis (> 50%)
Who cannot join
- Subject must be excluded from participation in this study if any of the following criteria are met
- Subjects presenting with de novo papilledema and severe visual field(VF) deficit (VF loss > -15db) that requires immediate surgical treatment without prior attempt of medical therapy.
- Currently has or plans to have an implanted CSF shunt.
- History of previously implanted intra-cranial sinus stent.
- Transverse-sigmoid sinus vessel size <5 mm or >10 mm.
- Creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min (except if patients is already on hemodialysis).
Show all 27Show fewer
- Allergic to imaging contrast media (iodine or gadolinium) despite premedication.
- Allergic to nitinol or nickel.
- Contra-indication to general anesthesia.
- Contra-indication to aspirin, clopidogrel or other anticoagulant.
- Hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinemia).
- Currently requiring full anti-coagulation for other medical reasons, such as atrial fibrillation (AF), artificial valves, deep vein thrombosis pulmonary embolism, etc.
- History of stroke or transient ischemic attack (TIA).
- History of AF or other risks of stroke.
- History of deep vein thrombosis or pulmonary embolism.
- History of severe chronic obstructive pulmonary disease or other severe respiratory disease.
- History of severe carotid atherosclerotic disease.
- History of heart failure, dilated cardiomyopathy, or congenital heart conditions, etc. that are at high thrombogenic risk.
- History of uncontrolled diabetes.
- Use (oral) of tetracycline derivative, retinoid or vitamin A during the last 3 months.
- Cerebral vascular lesions (arteriovenous malformation (AVM), arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis,intracranial artery dissection, etc.).
- Patient has visions loss due to other disease (e.g. cataract, macular degeneration, glaucoma, etc.).
- Inability to provide reliable and reproducible visual field examinations (>15% false positive errors and/or failure to maintain fixation for eye monitoring).
- For female subject of child bearing potential, pregnant or not willing to use contraception for 12 months.
- Presence of a physical, mental or social condition that could prevent adequate one-year follow-up (homelessness, drug dependency, anticipation of moving far away, life threatening disease, terminal illness).
- Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting (e.g multi-channel sinus)
- Currently enrolled in a premarket investigational study. Enrollment in a post market study that does not impact the River™ Stent procedure or device is allowed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UB Neurosurgery
Buffalo, New York, 14203
Baptist Health
Jacksonville, Florida, 32207
Northwell Health
Manhasset, New York, 11030
Weill Cornell Medicine
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH).
The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy.
The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.
Read the detailed description
Study objective: The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH)
Investigational product: Serenity River Stent System
Study design: prospective, multicenter, single arm, open label clinical trial
Subject population: IIH subjects with significant (>50%) stenosis of the transverse-sigmoid sinuses and moderate to severe visual field loss or severe headaches that have failed medical therapy. In the absence of this trial, subjects would have been offered a surgical treatment of IIH such as sinus stenting with an off-label device, cerebrospinal fluid shunting, or optic nerve sheath fenestration by the treating physician.
- For subjects with visual field loss: if moderate to severe visual field loss (mean deviation between -6db and -30 db) for at least 2 weeks despite escalation of acetazolamide to 1000 mg twice a day or if the visual field deteriorates by more than 2 db during treatment, or treatment intolerance.
- For subjects with headaches: if they have severe headaches (HIT > 59) for at least 4 weeks despite treatment with topiramate 100 mg twice a day or other headache medication, or treatment intolerance.
Enrollment size and sites: 39 subjects will be enrolled in up to 10 US sites.
Primary safety endpoint: Major Adverse Event at 12 months. The MAE is a composite of the following: moderate or severe stroke (NIHSS > 3), neurological death, perforation or thrombosis of sinus or cerebral vein, device distal embolization, need for target lesion revascularization or need for alternate IIH surgical procedure such as cerebrospinal fluid shunting or optic nerve sheath fenestration.
Primary probable benefit endpoint: a composite at 12 months of:
- Absence of significant (>50%) stenosis of the stented sinus on retrograde catheter venography and
- Trans-stent pressure gradient < 8 mm Hg and
- Clinically relevant improvement in the main clinical outcome per specific inclusion criteria and stabilization or better of the other:
- Headaches: if the specific inclusion criteria was headaches, improvement in the HIT- 6 scale by > 4 points and improvement or stabilization of visual field.
- Ophthalmic: if the specific inclusion criteria was visual field loss, improvement of visual field by > 29% of the baseline value in the study eye, stabilization or improvement in the fellow eye, and improvement or stabilization of headaches.
Study duration and follow-up: The subjects will be followed at 2 weeks, 3 months, 6 months and 12 months. At 12 months, clinical examination, lumbar puncture and retrograde catheter venography with manometry will be performed to evaluate the patency of the treated sinus and the absence of trans-stent pressure gradient. Subjects will be consented to be clinically followed annually for up to 5 years.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- Venous sinus stenting (Serenity River)
- Keywords
- idiopathic intracranial hypertension, 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 stenting (Serenity River)Device
Patient is placed under general anesthesia. From femoral vein access, a standard guide-catheter is advanced in the internal jugular vein (on the side considered for stenting). The sigmoid then transverse sinus is catheterized with a microcatheter and guide-wire and an exchange guide-wire is placed in the superior sagittal sinus. The River stent delivery catheter is advanced over the exchange guide-wire in the sigmoid then transverse sinus up to the torcula. The River stent is deployed to cover the entire transverse sinus and the proximal half of the sigmoid sinus. The catheters are removed and hemostasis obtained by using a closure device or manual compression. The patient is kept overnight in the hospital for observation.
| Study group | Role | What they receive |
|---|---|---|
| Venous sinus stenting | Experimental | Subjects will have stenting of the transverse-sigmoid sinus Receives: Device: Venous sinus stenting (Serenity River) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Event (MAE)
The MAE is a composite of the following:
Moderate or severe stroke (NIH stroke scale > 3) Neurological death Perforation of sinus or cerebral vein Thrombosis of sinus or cerebral vein Device distal embolization Need for target lesion revascularization or need for IIH alternate procedure (cerebrospinal fluid shunting or optic nerve sheath fenestration)
Measured: 12 months
Clinical improvement with no restenosis of the venous sinus
The primary probable benefit endpoint is a composite of:
- Absence of significant stenosis (defined as >50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND
- Trans-stent pressure gradient (measured during the RCV) < 8 mm Hg AND
- Clinically relevant improvement in the main clinical outcome per specific inclusion criteria (headache or ophthalmic) and stabilization or better of the other
Measured: 12 months
Secondary outcomes (11)
Individual components of MAE.
Components of MAE will be reported as individual event rates.
Measured: 12 months
Cerebrospinal fluid (CSF) opening pressure at 12 months
CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.
Measured: 12 months
Stent patency at 12 months
Stent patency will be assessed by retrograde catheter venography. Patency is defined as absence of significant (>50%) stenosis
Measured: 12 months
Medications
Change in IIH medications and dosage at 12 months compared to baseline
Measured: 12 months
Headaches
Change in headaches assessed using the Headache Impact Test (HIT-6) scale (minimum score 36, maximum 78; higher value represents worse headache) at 12 months compared to baseline.
Measured: 12 months
Papilledema
Change in papilledema grading using Frisen scale (Stage 0 to 5; stage 0 represents no papilledema and is the best outcome) at 12 months compared to baseline.
Measured: 12 months
Visual acuity
Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.
Measured: 12 months
Retinal Nerve Fiber Layer Thickness
Change in retinal nerve fiber layer thickness measured using Optical Coherence Tomography (OCT) at 12 months compared to baseline.
Measured: 12 months
Tinnitus
Change in the intensity of tinnitus evaluated on the Tinnitus Functional Index (TFI) score (overall score; minimum 0, maximum 100; 100 is the worst tinnitus with the worst negative impact) at 12 months compared to baseline.
Measured: 12 months
Quality of Life SF-12
Change in quality of life assessed with the Short Form health survey 12 items (SF-12) at 12 months compared to baseline
Measured: 12 months
Quality of Life NEI-VFQ-25
Change in quality of life assessed with the National Eye Institute - Visual Functioning Questionnaire - 25 at 12 months compared to baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start24 Aug 2018
- Primary completion1 Oct 2022
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- 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
- Model description
- Prospective, multicenter, single arm, open label clinical study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serenity Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Athos Patsalides, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556085
- Sponsor's protocol ID
- River 1111-001
- Status last verified
- Jun 2023
- First submitted
- 22 May 2018
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Albuquerque FC, Gross BA, Levitt MR. Time to re-assess the treatment of idiopathic intracranial hypertension. J Neurointerv Surg. 2016 Jun;8(6):549-50. doi: 10.1136/neurintsurg-2016-012460. No abstract available.
PubMed 27178402Abubaker K, Ali Z, Raza K, Bolger C, Rawluk D, O'Brien D. Idiopathic intracranial hypertension: lumboperitoneal shunts versus ventriculoperitoneal shunts--case series and literature review. Br J Neurosurg. 2011 Feb;25(1):94-9. doi: 10.3109/02688697.2010.544781.
PubMed 21323404Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.
PubMed 28255904Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.
PubMed 21799038Dinkin MJ, Patsalides A. Venous Sinus Stenting in Idiopathic Intracranial Hypertension: Results of a Prospective Trial. J Neuroophthalmol. 2017 Jun;37(2):113-121. doi: 10.1097/WNO.0000000000000426.
PubMed 27556959Kanagalingam S, Subramanian PS. Cerebral venous sinus stenting for pseudotumor cerebri: A review. Saudi J Ophthalmol. 2015 Jan-Mar;29(1):3-8. doi: 10.1016/j.sjopt.2014.09.007. Epub 2014 Sep 27.
PubMed 25859134Dinkin MJ, Patsalides A. Venous Sinus Stenting for Idiopathic Intracranial Hypertension: Where Are We Now? Neurol Clin. 2017 Feb;35(1):59-81. doi: 10.1016/j.ncl.2016.08.006.
PubMed 27886896
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT03556085
- Acronym / sponsor ID
- River 1111-001
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- idiopathic intracranial hypertension, venous sinus stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Serenity Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Jun 2018 (actual)
- 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.
The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH).
The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy.
The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.
Detailed description
Study objective: The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH)
Investigational product: Serenity River Stent System
Study design: prospective, multicenter, single arm, open label clinical trial
Subject population: IIH subjects with significant (>50%) stenosis of the transverse-sigmoid sinuses and moderate to severe visual field loss or severe headaches that have failed medical therapy. In the absence of this trial, subjects would have been offered a surgical treatment of IIH such as sinus stenting with an off-label device, cerebrospinal fluid shunting, or optic nerve sheath fenestration by the treating physician.
- For subjects with visual field loss: if moderate to severe visual field loss (mean deviation between -6db and -30 db) for at least 2 weeks despite escalation of acetazolamide to 1000 mg twice a day or if the visual field deteriorates by more than 2 db during treatment, or treatment intolerance.
- For subjects with headaches: if they have severe headaches (HIT > 59) for at least 4 weeks despite treatment with topiramate 100 mg twice a day or other headache medication, or treatment intolerance.
Enrollment size and sites: 39 subjects will be enrolled in up to 10 US sites.
Primary safety endpoint: Major Adverse Event at 12 months. The MAE is a composite of the following: moderate or severe stroke (NIHSS > 3), neurological death, perforation or thrombosis of sinus or cerebral vein, device distal embolization, need for target lesion revascularization or need for alternate IIH surgical procedure such as cerebrospinal fluid shunting or optic nerve sheath fenestration.
Primary probable benefit endpoint: a composite at 12 months of:
- Absence of significant (>50%) stenosis of the stented sinus on retrograde catheter venography and
- Trans-stent pressure gradient < 8 mm Hg and
- Clinically relevant improvement in the main clinical outcome per specific inclusion criteria and stabilization or better of the other:
- Headaches: if the specific inclusion criteria was headaches, improvement in the HIT- 6 scale by > 4 points and improvement or stabilization of visual field.
- Ophthalmic: if the specific inclusion criteria was visual field loss, improvement of visual field by > 29% of the baseline value in the study eye, stabilization or improvement in the fellow eye, and improvement or stabilization of headaches.
Study duration and follow-up: The subjects will be followed at 2 weeks, 3 months, 6 months and 12 months. At 12 months, clinical examination, lumbar puncture and retrograde catheter venography with manometry will be performed to evaluate the patency of the treated sinus and the absence of trans-stent pressure gradient. Subjects will be consented to be clinically followed annually for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single arm, open label clinical study
| Arm | Type | Receives |
|---|---|---|
| Venous sinus stenting | Experimental | Device: Venous sinus stenting (Serenity River)Subjects will have stenting of the transverse-sigmoid sinus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria to be eligible for participation in the study:
- Subject is > 18 year-old and has given informed consent.
- Diagnosis of IIH per Modified Dandy Criteria.
- CSF opening pressure is > 25 cm H2O.
- Radiological examination (magnetic resonance venography (MRV) or computed tomographic venography (CTV)) shows bilateral transverse-sigmoid venous sinus stenosis (> 50%) or unilateral stenosis of the dominant sinus with contralateral hypoplastic sinus.
Key exclusion criteria (27 listed)
- Subject must be excluded from participation in this study if any of the following criteria are met
- Subjects presenting with de novo papilledema and severe visual field(VF) deficit (VF loss > -15db) that requires immediate surgical treatment without prior attempt of medical therapy.
- Currently has or plans to have an implanted CSF shunt.
- History of previously implanted intra-cranial sinus stent.
- Transverse-sigmoid sinus vessel size <5 mm or >10 mm.
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 stenting (Serenity River)Patient is placed under general anesthesia. From femoral vein access, a standard guide-catheter is advanced in the internal jugular vein (on the side considered for stenting). The sigmoid then transverse sinus is catheterized with a microcatheter and guide-wire and an exchange guide-wire is placed in the superior sagittal sinus. The River stent delivery catheter is advanced over the exchange guide-wire in the sigmoid then transverse sinus up to the torcula. The River stent is deployed to cover the entire transverse sinus and the proximal half of the sigmoid sinus. The catheters are removed and hemostasis obtained by using a closure device or manual compression. The patient is kept overnight in the hospital for observation. | Device | Venous sinus stenting |
Primary outcome
Major Adverse Event (MAE)
Time frame: 12 months
The MAE is a composite of the following: Moderate or severe stroke (NIH stroke scale > 3) Neurological death Perforation of sinus or cerebral vein Thrombosis of sinus or cerebral vein Device distal embolization Need for target lesion revascularization or need for IIH alternate procedure (cerebrospinal fluid shunting or optic nerve sheath fenestration)
Clinical improvement with no restenosis of the venous sinus
Time frame: 12 months
The primary probable benefit endpoint is a composite of: 1. Absence of significant stenosis (defined as >50% stenosis of reference vessel diameter) of the main dural venous sinus on retrograde catheter venography (RCV) AND 2. Trans-stent pressure gradient (measured during the RCV) < 8 mm Hg AND 3. Clinically relevant improvement in the main clinical outcome per specific inclusion criteria (headache or ophthalmic) and stabilization or better of the other
11 secondary outcomes
Individual components of MAE.
Time frame: 12 months
Cerebrospinal fluid (CSF) opening pressure at 12 months
Time frame: 12 months
Stent patency at 12 months
Time frame: 12 months
Medications
Time frame: 12 months
Headaches
Time frame: 12 months
Papilledema
Time frame: 12 months
Visual acuity
Time frame: 12 months
Retinal Nerve Fiber Layer Thickness
Time frame: 12 months
Tinnitus
Time frame: 12 months
Quality of Life SF-12
Time frame: 12 months
Quality of Life NEI-VFQ-25
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 27178402Albuquerque FC, Gross BA, Levitt MR. Time to re-assess the treatment of idiopathic intracranial hypertension. J Neurointerv Surg. 2016 Jun;8(6):549-50. doi: 10.1136/neurintsurg-2016-012460. No abstract available.
- Results publication: PubMed 21323404Abubaker K, Ali Z, Raza K, Bolger C, Rawluk D, O'Brien D. Idiopathic intracranial hypertension: lumboperitoneal shunts versus ventriculoperitoneal shunts--case series and literature review. Br J Neurosurg. 2011 Feb;25(1):94-9. doi: 10.3109/02688697.2010.544781.
- Results publication: PubMed 28255904Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.
- Results publication: PubMed 21799038Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.
- Results publication: PubMed 27556959Dinkin MJ, Patsalides A. Venous Sinus Stenting in Idiopathic Intracranial Hypertension: Results of a Prospective Trial. J Neuroophthalmol. 2017 Jun;37(2):113-121. doi: 10.1097/WNO.0000000000000426.
- Results publication: PubMed 25859134Kanagalingam S, Subramanian PS. Cerebral venous sinus stenting for pseudotumor cerebri: A review. Saudi J Ophthalmol. 2015 Jan-Mar;29(1):3-8. doi: 10.1016/j.sjopt.2014.09.007. Epub 2014 Sep 27.
- Results publication: PubMed 27886896Dinkin MJ, Patsalides A. Venous Sinus Stenting for Idiopathic Intracranial Hypertension: Where Are We Now? Neurol Clin. 2017 Feb;35(1):59-81. doi: 10.1016/j.ncl.2016.08.006.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Intracranial Hypertension
Not yet recruitingObservational study
Multimodal MRI Assessment of Brain Fluid Circulation in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Active, not recruitingObservational study
Disease Biosignatures in ALS/FTD Spectrum: New Impactful Biological Perspectives Beyond Clinical Approaches
ALS (Amyotrophic Lateral Sclerosis), FTD
Active, not recruiting
Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary Management
Idiopathic Intracranial Hypertension
Not yet recruitingPhase 3
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension (IIH)
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 principal investigator
Northwell Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous sinus stenting (Serenity River) in people with Idiopathic Intracranial Hypertension, run by Serenity Medical, Inc. at 6 sites 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 11 inclusion and 27 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
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?
Major Adverse Event (MAE) (time frame: 12 months). The study lists 2 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 NCT03556085, which also lists 7 linked publications.
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 22 Jun 2023.