Venous Sinus Stenting for Intracranial Hypertension

Not currently recruiting at 5 trial locations

Overseen By Sew-Wah Tay, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Serenity Medical, Inc.

Must be taking: Acetazolamide, Topiramate

Must not be taking: Anticoagulants, Tetracycline, Retinoid, Vitamin A

Disqualifiers: Stroke, Heart failure, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for idiopathic intracranial hypertension (IIH), a condition where high pressure inside the skull causes severe headaches or vision problems. The study uses the Serenity River stent to relieve these symptoms by improving blood flow in the brain. It seeks participants with IIH who experience severe headaches or significant vision loss unresponsive to medication. The goal is to determine if this stent is safe and effective in reducing symptoms. As an unphased trial, this study offers a unique opportunity to contribute to understanding a new treatment option for IIH.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on full anticoagulation therapy for other medical reasons, you may not be eligible to participate.

What prior data suggests that venous sinus stenting is safe for treating idiopathic intracranial hypertension?

Research has shown that venous sinus stenting is safe for people with idiopathic intracranial hypertension (IIH) who haven't improved with medication. One study found the River stent to be safe over a year. This stent is specifically designed for veins in the brain and is gentler than those used for arteries.

Another study confirmed the safety of venous sinus stenting in IIH patients. Most participants experienced improvements in symptoms such as ringing in the ears, vision problems, and headaches. However, about 13.7% of patients experienced some side effects.

These findings suggest that the treatment is generally well-tolerated, but like any procedure, it carries potential risks. Participants should understand these risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Venous sinus stenting, like the Serenity River treatment, is unique because it directly addresses the root cause of intracranial hypertension by restoring normal blood flow in the brain. Unlike the standard treatments, which often involve medications like diuretics or lumbar punctures to manage symptoms, this procedure offers a more permanent solution by physically widening narrowed veins. Researchers are excited about this approach because it has the potential to provide long-lasting relief and significantly improve the quality of life for patients who suffer from this condition.

What evidence suggests that venous sinus stenting is effective for idiopathic intracranial hypertension?

Research has shown that venous sinus stenting, which participants in this trial will undergo, can effectively treat idiopathic intracranial hypertension (IIH), especially for patients who haven't improved with medication. This procedure widens narrowed veins in the brain, helping to lower pressure and improve symptoms like severe headaches and vision problems. The River study found that the stenting procedure was safe and suggested it could relieve symptoms in IIH patients over a year. Other research indicates that this method is a promising option for people with IIH whose symptoms worsen despite medication. Overall, venous sinus stenting offers hope for those struggling with this condition. ^{1 2 5 6 7}

Who Is on the Research Team?

Athos Patsalides, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

Adults over 18 with idiopathic intracranial hypertension (IIH) who have severe headaches or visual field loss despite medical treatment may qualify. They should show evidence of venous sinus stenosis and not be candidates for other surgical interventions if this trial wasn't available. Exclusions include those with certain allergies, severe health conditions, pregnant women not using contraception, and others at high risk for complications.

Inclusion Criteria

You have a narrowing of the veins in your head.

A special kind of X-ray shows narrow veins in your head.

The pressure in your spinal fluid is too high.

Exclusion Criteria

You currently have or plan to have a surgically implanted tube to drain fluid from your brain.

You are allergic to the dye used for imaging tests, even with pre-treatment.

I have a heart condition that increases my risk of blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will have stenting of the transverse-sigmoid sinus using the Serenity River Stent System

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 2 weeks, 3 months, 6 months, and 12 months

12 months

4 visits (in-person)

Long-term follow-up

Participants will be clinically followed annually for up to 5 years to assess long-term outcomes

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Serenity River

Trial Overview The trial is testing the safety and potential benefits of the River stent to relieve symptoms in patients with IIH by placing it in the transverse-sigmoid sinus. The main goals are to check for major adverse events within a year and improvement in symptoms without significant sinus stenosis.

How Is the Trial Designed?

Group I: Venous sinus stenting Experimental Treatment 1 Intervention

Subjects will have stenting of the transverse-sigmoid sinus

Who Is Running the Clinical Trial?

Serenity Medical, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39978822/

The River study: the first prospective multicenter trial of a ... The River study 1- year results establish safety and suggest efficacy for venous sinus stenting in IIH subjects who have failed medical therapy.

2. jnis.bmj.com jnis.bmj.com/content/neurintsurg/early/2025/04/29/jnis-2024-022540/DC1/embed/inline-supplementary-material-1.pdf?download=true

Clinical Evaluation of the Serenity River™ Stent System to ... 7 In both intrinsic and extrinsic cases, opening of the transverse sinus by intra-vascular stenting has shown to be effective in reducing the ...

3. evtoday.com evtoday.com/news/serenitys-river-venous-sinus-stent-studied-to-treat-idiopathic-intracranial-hypertension

Serenity's River Venous Sinus Stent Studied to Treat ... The trial evaluated the company's River venous sinus stent for the treatment of idiopathic intracranial hypertension (IIH) in patients who are refractory or ...

4. nyp.org nyp.org/advances/article/ophthalmology/illuminating-a-novel-approach-to-idiopathic-intracranial-hypertension-venous-sinus-stenting

Illuminating a Novel Approach to Idiopathic Intracranial ... The findings confirm that venous sinus stenting is a viable treatment option for medically refractory IIH patients, especially when papilledema threatens their ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03556085?cond=IIH%20-%20Idiopathic%20Intracranial%20Hypertension&term=Pseudotumor%20Cerebri&intr=stent&rank=7

Venous Sinus Stenting With the River Stent in IIH 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 ...

6. neuronewsinternational.com neuronewsinternational.com/safety-of-venous-sinus-stenting-in-iih-patients-established-via-one-year-river-study-results/

Safety of venous sinus stenting in IIH patients established ... A prospective study has established the safety of venous sinus stenting (VSS) using a novel device in idiopathic intracranial hypertension (IIH) patients.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022510X24000832

Venous sinus stenting for idiopathic intracranial hypertension Clinical outcomes demonstrated improvement in tinnitus (95%), papilledema (89%), visual disturbances (88%), and headache (79%). However, 13.7% ...