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

Korábbi kezelés

• Subject previously treated with acetazolamide for IIH
• 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
• History of previously implanted intra-cranial sinus stent
• Previous gastric bypass surgery
• Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date

Más betegség

• 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
• Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
• 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.).

Laborértékek

• Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
• Patients with renal failure (creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min, except if patient is already on hemodialysis)

Egyéb

• 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
• 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.
• Life expectancy under 6 months
• Chronic IIH
• Contra-indication to general anesthesia
• Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
• 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
• 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)

• 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