Venous Sinus Stenting for Intracranial Hypertension

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

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if placing a small tube (stent) in a brain vein can safely help patients with severe headaches or vision problems due to high brain pressure. These patients haven't improved with medication. The stent works by keeping the vein open to reduce pressure. This method has shown promising results in patients who haven't responded to other treatments.

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.

Is venous sinus stenting generally safe for humans?

Venous sinus stenting is generally considered safe, with serious complications rarely reported. However, there have been instances of severe adverse events, such as cerebellar hemorrhage, which highlight the need for careful technique and further safety assessment in clinical trials. ^{1 2 3 4 5}

How is the treatment Serenity River different from other treatments for intracranial hypertension?

Venous sinus stenting, like the treatment Serenity River, is unique because it involves placing a small tube (stent) in the veins of the brain to relieve pressure, which is different from other treatments that might focus on medication or surgery. This approach is particularly useful for patients with narrowed veins in the brain, offering a targeted solution to improve blood flow and reduce symptoms. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Serenity River for intracranial hypertension?

Research shows that venous sinus stenting, a treatment for intracranial hypertension, is effective in improving symptoms for patients who do not respond to other treatments. Studies indicate that this approach is safe and successful, offering a promising alternative to more invasive procedures. ^{3 5 6 11 12}

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. England pubmed.ncbi.nlm.nih.gov

Long-term patency of venous sinus stents for idiopathic intracranial hypertension. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safely traversing venous sinus stenosis: The "Cobra" technique. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Venous sinus stenting in idiopathic intracranial hypertension: a safer surgical approach? [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Venous Sinus Stenting in Idiopathic Intracranial Hypertension: Results of a Prospective Trial. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Intracranial venous stenting for idiopathic intracranial hypertension. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Major complications of dural venous sinus stenting for idiopathic intracranial hypertension: case series and management considerations. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Severe cerebellar hemorrhage following transverse sinus stenting for idiopathic intracranial hypertension. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Analysis of emergency venous sinus stenting in the treatment of acute visual impairment caused by idiopathic cranial hypertension]. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Patency of the vein of Labbé after venous stenting of the transverse and sigmoid sinuses. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Fifty shades of gradients: does the pressure gradient in venous sinus stenting for idiopathic intracranial hypertension matter? A systematic review. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Retrograde 3D rotational venography (3DRV) for venous sinus stent placement in idiopathic intracranial hypertension. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Unique variant of idiopathic intracranial hypertension dural sinus stenting. [2022]