Venous Sinus Stenting With the River Stent in IIH (NCT03556085)
Clinical Evaluation of the Serenity River Stent System to Treat Idiopathic Intracranial Hypertension
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Baptist Health — Jacksonville, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Baptist Health — Jacksonville, Florida
- UB Neurosurgery — Buffalo, New York
- Northwell Health — Manhasset, New York
- Weill Cornell Medicine — New York, New York
- Wake Forest University Health Sciences — Winston-Salem, North Carolina
- Oregon Health & Science University — Portland, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Idiopathic Intracranial Hypertension
- Evaluating Raised Intracranial Pressure Using MR Elastography — Rochester, Minnesota
Explore by condition: All Idiopathic Intracranial Hypertension clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.