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.
• Subject Eligibility Criteria
‣ Diagnosis of IIH by modified Dandy criteria for more than 2 months
⁃ Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment
⁃ Normal cerebrospinal fluid (CSF) composition
⁃ Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI
⁃ Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg
⁃ Patients or their relatives signed written informed consent
• Ophthalmic Eligibility Criteria:
‣ At least one eye had the presence of papilledema
⁃ At 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)