Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase

Recruiting now · Not applicable

Conditions studied: Idiopathic Intracranial Hypertension (IIH)

In brief

This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Key facts

Study ID

NCT06919744

Run by

University Hospital, Montpellier

People needed

114

Starts

2025-09-19

Expected to finish

2029-04-30

Last updated by the study team

2025-10-03

Who can join

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

You may qualify if…

• Subject is ≥ 18 years old at inclusion.
• Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
• Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
• Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
• Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
• Subject without macular ganglion cells atrophy seen on OCT
• Patient having received information about data collection and having signed and dated an Informed Consent Form
• Subjects must be able to attend all scheduled visits and to comply with all trial procedures
• Subjects must be covered by public health insurance

You may not qualify if…

• Subject previously treated with acetazolamide for IIH
• Known contrast product, Nickel, titanium allergy
• Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
• History of intracranial venous thrombosis or intracranial neoplasia
• Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB
• Macular ganglion cells atrophy seen on OCT
• Optic nerve atrophy
• Amblyopia
• Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss
• Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
• Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
• Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
• Life expectancy under 6 months
• Chronic IIH
• Patients with renal failure (creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min, except if patient is already on hemodialysis)
• History of previously implanted intra-cranial sinus stent
• Previous gastric bypass surgery
• Contra-indication to general anesthesia
• Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
• History of chronic obstructive pulmonary disease or other severe respiratory disease
• History of deep vein thrombosis or pulmonary embolism
• History of atrial fibrillation or other risks of stroke
• Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery dissection, etc.).
• Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
• Subject who are in a dependency or employment with the sponsor or the investigator

Where it is running

• CHU de Montpellier Hôpital Gui de Chauliac — Montpellier, France (enrolling)
• CHU de REIMS — Reims, France
• CHU de Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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