RecruitingNot ApplicableNCT06919744

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

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

Sponsor

University Hospital, Montpellier

Enrollment

114 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

Idiopathic Intracranial Hypertension (IIH)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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

Exclusion Criteria27

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
Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)