Venous Sinus Stenting for Intracranial Hypertension

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byAthos Patsalides, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Serenity Medical, Inc.

No Placebo Group

Trial Summary

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.

Research Team

Athos Patsalides, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.

I am over 18 years old and have agreed to participate.

See 7 more

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.

See 23 more

Treatment Details

Interventions

Serenity River (Stent)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Venous sinus stentingExperimental Treatment1 Intervention

Subjects will have stenting of the transverse-sigmoid sinus