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

Recruiting now · Phase 3

Conditions studied: Idiopathic Intracranial Hypotension, Venous Sinus Stenosis

In brief

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

Key facts

Study ID

NCT05707442

Run by

Beijing Tiantan Hospital

People needed

74

Starts

2023-02-16

Expected to finish

2027-03-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject Eligibility 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
• 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)

You may not qualify if…

• Subject 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
• Known hereditary or acquired haemorrhagic diathesis
• Known hereditary or acquired thrombophilia
• Platelet counts or coagulation abnormality
• Major surgery or severe trauma or any traumatic brain injury within the previous 14 days
• A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor
• Other 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 anesthesia
• Increased intracranial pressure due to other secondary factors
• Ophthalmic Exclusion Criteria:
• Current intraocular pressure > 28mmHg or previous intraocular pressure > 30mmHg
• Refractive 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)

Where it is running

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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