Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Inclusion Criteria:Subject Eligibility CriteriaDiagnosis of IIH by modified Dandy criteria for more than 2 monthsLumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollmentNormal cerebrospinal fluid (CSF) compositionNeuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRILocalized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHgPatients or their relatives signed written informed consentOphthalmic Eligibility Criteria:At least one eye had the presence of papilledemaAt least one eye of visual field loss: PMD ranging from - 2dB and below; decreased visual function on automated perimetry was reproducible with a false-positive rate of no more than 15%Visual acuity above 20 / 200 (≥ 39 letters)Exclusion Criteria:Subject Exclusion CriteriaPrevious surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stentingVisual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc)Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressureDSA showed diffused venous sinus stenosis, cortical or deep vein stenosisA history of severe thyroid disease and iodine allergyPregnant or lactating womenSevere cardiopulmonary, liver or kidney failureKnown hereditary or acquired haemorrhagic diathesisKnown hereditary or acquired thrombophiliaPlatelet counts or coagulation abnormalityMajor surgery or severe trauma or any traumatic brain injury within the previous 14 daysA history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumorOther life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesiaIncreased intracranial pressure due to other secondary factorsOphthalmic Exclusion Criteria:Current intraocular pressure > 28mmHg or previous intraocular pressure > 30mmHgRefractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases:Myopia of - 6.0D to - 8.0D with the following: 1)There was no myopia related disease that can lead to decreased vision under the eyeground microscope (eg, scleral staphyloma, retinal thinning at the posterior pole, and moderate to severe disc tilt); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.Hyperopia of +6.0D to +8.0D with the following: 1) The presence of a well characterized peri optic disc edematous halo, as opposed to crowded small optic discs or other features of decreased visual acuity associated with hyperopic changes, was at the discretion of the site investigator or reading center leader (or his designee); 2) The patient wore contact lenses of appropriate degree for all visual field examinations.Examination visible or past medical history known to have large optic disc drusen (persistent optic disc edema can present with small optic disc drusen, as low numbers are acceptable for inclusion and to be determined by the investigator to be unrelated to vision loss)