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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test whether stenting the transverse-sigmoid sinus is safe and can help relieve symptoms in people with idiopathic intracranial hypertension.
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.Check my eligibility
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.See study design
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 belowSelect...
I have severe headaches or vision loss despite treatment.
Select...
I have severe headaches or vision loss due to increased brain pressure.
Select...
I experience symptoms of increased brain pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical improvement with no restenosis of the venous sinus
Major Adverse Event (MAE)
Secondary outcome measures
Cerebrospinal fluid (CSF) opening pressure at 12 months
Headaches
Individual components of MAE.
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Venous sinus stentingExperimental Treatment1 Intervention
Subjects will have stenting of the transverse-sigmoid sinus
Find a Location
Who is running the clinical trial?
Serenity Medical, Inc.Lead Sponsor
Athos Patsalides, MDPrincipal InvestigatorNorthwell Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a narrowing of the veins in your head.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.A special kind of X-ray shows narrow veins in your head.I have severe vision loss and swelling in my optic nerve needing urgent surgery.You have had a sinus stent implanted in your head before.I have a severe lung condition like COPD.I have a severe blockage in my neck arteries.I have not taken tetracycline, retinoids, or vitamin A in the last 3 months.My veins are normal and safe for catheterization and stenting.I am over 18 years old and have agreed to participate.My kidney function is reduced, but I'm not on dialysis.I cannot take aspirin, clopidogrel, or similar blood thinners due to health reasons.I am on full anti-coagulation treatment for a condition like AF or DVT.I have a history of atrial fibrillation or risk factors for stroke.I have vision loss from a condition like cataract or glaucoma.You cannot reliably complete visual field tests or keep your eyes still during monitoring.I am not pregnant and willing to use contraception for 12 months.The pressure in your spinal fluid is too high.I have severe headaches or vision loss due to increased brain pressure.I would have been offered surgery for my condition if not for this study.I have had a stroke or a transient ischemic attack.You have been diagnosed with IIH according to specific criteria called the Modified Dandy Criteria.I have severe headaches or vision loss despite treatment.A special test shows high pressure in a specific blood vessel in your brain.I have a condition that makes my blood clot more easily.I have had a deep vein thrombosis or pulmonary embolism.I cannot have general anesthesia due to health reasons.I have diabetes that is not well-controlled.The size of certain blood vessels in your brain is less than 5 mm or more than 10 mm.I do not have significant brain vessel issues like AVM, aneurysms, or severe narrowing.I experience symptoms of increased brain pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Venous sinus stenting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pseudotumor Cerebri Patient Testimony for trial: Trial Name: NCT03556085 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aims are researchers attempting to achieve through this research endeavor?
"This trial, which is slated to run for about a year, will assess its primary outcome of Major Adverse Event (MAE). Secondary objectives include evaluating Stent patency at 12 months with retrograde catheter venography and determining Visual acuity using the Early treatment Diabetic Retinopathy (ETDRS) chart. The Cerebrospinal fluid (CSF) opening pressure at 12 months will be determined through lumbar puncture in the lateral decubitus position."
Answered by AI
Are there any openings currently available for participation in this trial?
"This research endeavour, which was first made public on August 24th 2018, is not actively recruiting patients. However, clinicaltrials.gov lists over 750 other studies that are accepting new participants right now."
Answered by AI
How many healthcare facilities are currently engaged in this clinical trial?
"Wake Forest University Health Sciences situated in Winston-Salem, North carolina, Baptist Health located in Jacksonville, Florida, and Oregon Health & Science University located in Portland, Oregon serve as the primary locations for this clinical trial. An additional 6 sites are also participating in the study."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Oregon Health & Science University
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I underwent venous sinus stenting and want my case to help others.
PatientReceived 1 prior treatment
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