NCT06945848 Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

Eligibility & Interventions

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This trial targets 114 participants in total. It began in 2026-01-05 with a primary completion date of 2029-01-05.

Brief Summary

This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and/or tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy). 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 care + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

Eligibility Criteria

Inclusion Criteria: 1. Subject is ≥ 18 years old at inclusion. 2. Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year 3. Patient with elevated intracranial pressure defined as \> 25 cm H20 or 18 mmHg 4. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI 5. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities 6. Patient having received information about data collection and having signed and dated an Informed Consent Form 7. Subjects must be able to attend all scheduled visits and to comply with all trial procedures 8. Subjects must be covered by public health insurance Exclusion Criteria: 1. Patients receiving topiramate in the previous month 2. Known contrast product, Nickel, titanium allergy 3. Exposure to an oral drug (other than ACZ), substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds) 4. History of intracranial venous thrombosis or intracranial neoplasia 5. 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 6. Optic nerve atrophy 7. Amblyopia 8. 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 9. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive 10. 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. 11. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.) 12. Life expectancy under 6 months 13. Patients with renal failure (creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min, except if patient is already on hemodialysis) 14. History of previously implanted intra-cranial sinus stent 15. Previous gastric bypass surgery AAP-DGOS PHRC-N 22\_0175 CHU DE MONTPELLIER Pr Costalat Vincent/Pr Ducros Anne Version n°2.2 date 25/03/2025 Page 28 sur 63 16. Contra-indication to general anesthesia 17. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant 18. History of chronic obstructive pulmonary disease or other severe respiratory disease 19. History of deep vein thrombosis or pulmonary embolism 20. History of atrial fibrillation or other risks of stroke 21. 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.). 22. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting 23. Subject who are in a dependency or employment with the sponsor or the investigator 24. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date 25. 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)

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