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NCT03556085 · ClinicalTrials.gov registry record · NA
Venous Sinus Stenting With the River Stent in IIH
A NA study of Idiopathic Intracranial Hypertension, sponsored by Serenity Medical.
- Active
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 6
- Study locations
NCT03556085: Active NA study of Idiopathic Intracranial Hypertension, sponsored by Serenity Medical.
NCT03556085 is a NA study of Idiopathic Intracranial Hypertension that is active but no longer recruiting, run by Serenity Medical. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03556085, a NA study of Idiopathic Intracranial Hypertension, is active but no longer recruiting, sponsored by Serenity Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
The MAE is a composite of the following: Moderate or severe stroke (NIH stroke scale \> 3) Neurological death Perforation of sinus or cerebral vein Thrombosis of sinus or cerebral vein Device distal embolization Need for target lesion revascularization or need for IIH alternate procedure (cerebrospinal fluid shunting or optic nerve sheath fenestration)
Conditions Studied
Interventions
- DEVICE Venous sinus stenting (Serenity River)
Study Locations (6)
New York
- UB Neurosurgery - Buffalo
- Northwell Health - Manhasset
- Weill Cornell Medicine - New York
Florida
- Baptist Health - Jacksonville
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2026-11-01 |
| Phase | NA |
What the registry record for NCT03556085 still lists
NCT03556085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Idiopathic Intracranial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Venous sinus stenting (Serenity River) is the first listed.
NCT03556085 lists 6 locations in 4 states (New York, Florida, North Carolina).
Frequently Asked Questions
What is clinical trial NCT03556085 about?
NCT03556085 is a clinical study titled "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 symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field...
What is the current status of trial NCT03556085?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 39 participants. The study started on 2018-08-24. Estimated completion is 2026-11-01.
What conditions does trial NCT03556085 study?
This clinical trial studies the following conditions: Idiopathic Intracranial Hypertension.
What interventions are being tested in trial NCT03556085?
The interventions under investigation include: Venous sinus stenting (Serenity River) (DEVICE).
Who is sponsoring clinical trial NCT03556085?
This trial is sponsored by Serenity Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03556085 being conducted?
This trial has 6 study locations across Florida, New York, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03556085's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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