RecruitingPhase 3

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

China74 participantsStarted 2023-02-16

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Diagnosis of IIH by modified Dandy criteria about 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
✓. 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%

Exclusion criteria

✕. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting
✕. Progressive or rapid visual loss needed urgent surgical intervention; if delay\>24-48 h consider interim lumbar drain (for rapid visual loss only).Surgical options to consider: CSF diversion or optic nerve sheath fenestration
✕. Visual 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 pressure
✕. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis
✕. A history of severe thyroid disease and iodine allergy
✕. Pregnant or lactating women
✕. Severe cardiopulmonary, liver or kidney failure

What they're measuring

Perimetric Mean Deviation (PMD)

Timeframe: 6 months

Trial details

NCT IDNCT05707442

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Xu Tong, MD

+8617611338800 dongri0514@sina.com

View on ClinicalTrials.gov More Idiopathic Intracranial Hypotension trials