An interventional study of Venous sinus stenting (Serenity River) in Idiopathic Intracranial Hypertension, sponsored by Serenity Medical, Inc.. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Serenity Medical, Inc. · Not applicable, Interventional, and Treatment
Among 16 studies in Pseudotumor Cerebri with a site in United States — 2 open to participants now, 5 under way, none of them phase 3. Pseudotumor Cerebri · United States.
Among the 16 studies in Pseudotumor Cerebri with a site in United States, this one is the 6th largest by enrollment of the 11 interventional ones, is the only one that started in 2018, is one of 6 with no phase, and was the 10th registered.
53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.
This study's enrollment of 39 is below the median of 60 across 35 interventional studies indexed under Pseudotumor Cerebri.
Browse Pseudotumor Cerebri studies →2 of the 16 studies in Pseudotumor Cerebri with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 14 Pseudotumor Cerebri studies recruiting now, 7 (50%) set no upper age limit and 5 (36%) stop at 75 or younger; 0 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
Median enrollment 39 across the 11 interventional studies, 18 across the 5 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
3 of 16 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Serenity Medical, Inc. as lead sponsor.
Serenity Medical, Inc. has 1 study filed under Pseudotumor Cerebri — fewer than ten, so there is no comparison to draw.
1 of the studies in Pseudotumor Cerebri with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07191873Duke UniversityTirzepatide in Idiopathic Intracranial Hypertension Trial | 2027-08 |
Among the 16 studies in Pseudotumor Cerebri with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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:
Clinically relevant improvement in the main clinical outcome per specific inclusion criteria and stabilization or better of the other:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following criteria to be eligible for participation in the study:
Exclusion Criteria:
Subject must be excluded from participation in this study if any of the following criteria are met
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will have stenting of the transverse-sigmoid sinus
Device: 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.
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)
Time frame: 12 months
Clinical improvement with no restenosis of the venous sinus
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
Time frame: 12 months
Individual components of MAE.
Components of MAE will be reported as individual event rates.
Time frame: 12 months
Cerebrospinal fluid (CSF) opening pressure at 12 months
CSF opening pressure will be measured via lumbar puncture in the lateral decubitus position.
Time frame: 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
Time frame: 12 months
Medications
Change in IIH medications and dosage at 12 months compared to baseline
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Visual acuity
Change in visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart at 12 months compared to baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 12 months
Plan to share: No
Ran from Aug 2018 to primary completion in Oct 2022, 49 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.