Venous Sinus Stenting With the River Stent in IIH (NCT03556085) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Venous Sinus Stenting With the River Stent in IIH
United States39 participantsStarted 2018-08-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is \> 18 year-old and has given informed consent.
. Diagnosis of IIH per Modified Dandy Criteria.
. CSF opening pressure is \> 25 cm H2O.
. Radiological examination (magnetic resonance venography (MRV) or computed tomographic venography (CTV)) shows bilateral transverse-sigmoid venous sinus stenosis (\> 50%) or unilateral stenosis of the dominant sinus with contralateral hypoplastic sinus.
. Presence of IIH clinical symptoms (6. OR 7.)
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Adverse Event (MAE)
Timeframe: 12 months
2
Clinical improvement with no restenosis of the venous sinus
. 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.
. In the absence of this study, the subject would have been offered a surgical intervention by Optic Nerve Sheath Fenestration (ONSF), Cerebro Spinal Fluid (CSF) shunting procedure, or venous sinus stenting with an off-label device.
Exclusion criteria
. 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.
. Currently has or plans to have an implanted CSF shunt.
. History of previously implanted intra-cranial sinus stent.
. Transverse-sigmoid sinus vessel size \<5 mm or \>10 mm.
. Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
. Allergic to imaging contrast media (iodine or gadolinium) despite premedication.