Venous Sinus Stenting With the River Stent in IIH

Running, not enrolling · Not applicable

Conditions studied: Idiopathic Intracranial Hypertension

In brief

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.

Key facts

Study ID

NCT03556085

Run by

Serenity Medical, Inc.

People needed

39

Starts

2018-08-24

Expected to finish

2026-11-01

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for participation in the study:
• 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
• 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.
• Catheter manometry shows a pressure gradient > 8 mm Hg across the transverse sigmoid sinus stenosis.
• Venographic evidence of sinus stenosis (> 50%)

You may not qualify if…

• Subject must be excluded from participation in this study if any of the following criteria are met
• 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.
• Allergic to nitinol or nickel.
• Contra-indication to general anesthesia.
• Contra-indication to aspirin, clopidogrel or other anticoagulant.
• Hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinemia).
• Currently requiring full anti-coagulation for other medical reasons, such as atrial fibrillation (AF), artificial valves, deep vein thrombosis pulmonary embolism, etc.
• History of stroke or transient ischemic attack (TIA).
• History of AF or other risks of stroke.
• History of deep vein thrombosis or pulmonary embolism.
• History of severe chronic obstructive pulmonary disease or other severe respiratory disease.
• History of severe carotid atherosclerotic disease.
• History of heart failure, dilated cardiomyopathy, or congenital heart conditions, etc. that are at high thrombogenic risk.
• History of uncontrolled diabetes.
• Use (oral) of tetracycline derivative, retinoid or vitamin A during the last 3 months.
• Cerebral vascular lesions (arteriovenous malformation (AVM), arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis,intracranial artery dissection, etc.).
• Patient has visions loss due to other disease (e.g. cataract, macular degeneration, glaucoma, etc.).
• Inability to provide reliable and reproducible visual field examinations (>15% false positive errors and/or failure to maintain fixation for eye monitoring).
• For female subject of child bearing potential, pregnant or not willing to use contraception for 12 months.
• Presence of a physical, mental or social condition that could prevent adequate one-year follow-up (homelessness, drug dependency, anticipation of moving far away, life threatening disease, terminal illness).

Where it is running

• Baptist Health — Jacksonville, Florida, United States
• UB Neurosurgery — Buffalo, New York, United States
• Northwell Health — Manhasset, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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