What side effects are associated with this type of intervention?

The most common treatment for Pseudotumor Cerebri involving mechanical dilation, such as the River Stent, aims to relieve intracranial pressure by stenting the transverse-sigmoid sinus. Known side effects of such procedures can include headache, visual disturbances, and potential complications related to the stent placement, such as infection, bleeding, or stent migration. These treatments are generally considered when medical therapy fails, and while they can be effective, they carry risks associated with invasive procedures.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Pseudotumor Cerebri that involve mechanical dilation or stenting of the transverse-sigmoid sinus. However, dural venous sinus stenting has been explored in clinical studies as a potential treatment for medically refractory IIH with promising results. These studies suggest that stenting can safely relieve intracranial pressure and improve symptoms such as papilledema and headaches. Further investigation and clinical trials, such as those involving the River Stent, are ongoing to establish the efficacy and safety of this approach.

What other types of research exist?

Promising novel alternatives to the River Stent for treating Pseudotumor Cerebri include: 1) Venous sinus stenting with other advanced stents designed for better efficacy and safety profiles. 2) Pharmacological treatments targeting the underlying pathophysiology of IIH, such as new formulations of carbonic anhydrase inhibitors or novel diuretics. 3) Minimally invasive surgical options like optic nerve sheath fenestration or cerebrospinal fluid (CSF) diversion procedures with improved shunt technologies. 4) Non-invasive therapies such as weight management programs and lifestyle modifications, which have shown potential in reducing intracranial pressure in IIH patients.

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Stent

Venous Sinus Stenting for Intracranial Hypertension

N/A

Waitlist Available

Led By Athos Patsalides, MD

Research Sponsored by Serenity Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Presence of IIH clinical symptoms (Headaches: Score > 59 on the HIT-6 scale, refractory to medical therapy, 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).

Must not have

History of heart failure, dilated cardiomyopathy, or congenital heart conditions, etc. that are at high thrombogenic risk.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects might include discomfort at the insertion site, allergic reactions to materials like nitinol or nickel used in the stent, blood clotting issues due to anti-clotting medications required post-procedure, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe headaches or vision loss despite treatment.

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I have severe headaches or vision loss due to increased brain pressure.

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I experience symptoms of increased brain pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe vision loss and swelling in my optic nerve needing urgent surgery.

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I have a severe lung condition like COPD.

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I have a severe blockage in my neck arteries.

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My veins are normal and safe for catheterization and stenting.

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My kidney function is reduced, but I'm not on dialysis.

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I cannot take aspirin, clopidogrel, or similar blood thinners due to health reasons.

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I am on full anti-coagulation treatment for a condition like AF or DVT.

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I have a history of atrial fibrillation or risk factors for stroke.

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I have vision loss from a condition like cataract or glaucoma.

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I am not pregnant and willing to use contraception for 12 months.

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I have a condition that makes my blood clot more easily.

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I have had a stroke or a transient ischemic attack.

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I have had a deep vein thrombosis or pulmonary embolism.

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I cannot have general anesthesia due to health reasons.

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I have diabetes that is not well-controlled.

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I do not have significant brain vessel issues like AVM, aneurysms, or severe narrowing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical improvement with no restenosis of the venous sinus

Major Adverse Event (MAE)

Secondary study objectives

Cerebrospinal fluid (CSF) opening pressure at 12 months

Headaches

Individual components of MAE.

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venous sinus stentingExperimental Treatment1 Intervention

Subjects will have stenting of the transverse-sigmoid sinus

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pseudotumor Cerebri include medications like acetazolamide, which reduces cerebrospinal fluid (CSF) production, and surgical options such as optic nerve sheath fenestration and CSF shunting, which help to drain excess fluid. The River Stent, a mechanical dilation treatment, targets the transverse-sigmoid sinus to relieve intracranial pressure by improving venous outflow. This is crucial for IIH patients as it directly addresses the underlying issue of impaired CSF absorption and venous outflow, thereby reducing symptoms like severe headaches and visual disturbances.