Actively Recruiting
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Led by Beijing Tiantan Hospital · Updated on 2026-02-10
74
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.
CONDITIONS
Official Title
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic intracranial hypertension (IIH) by modified Dandy criteria for more than 2 months
- Lumbar puncture opening pressure of 250 mmH2O or higher within 6 weeks before enrollment
- Normal cerebrospinal fluid composition
- Brain imaging showing normal brain tissue without hydrocephalus, mass, or structural lesions and no meningeal enhancement
- Localized venous sinus stenosis with 50% or greater narrowing and pressure gradient of 8 mmHg or more
- Written informed consent signed by patients or their relatives
- Presence of papilledema in at least one eye
- Visual field loss in at least one eye with perimetric mean deviation (PMD) of -2 dB or lower
- Visual acuity better than 20/200 (at least 39 letters)
You will not qualify if you...
- Previous surgery for IIH including optic nerve sheath fenestration, CSF shunting, decompressive craniectomy, or venous sinus stenting
- Progressive or rapid visual loss requiring urgent surgery or intervention
- Visual loss caused by other eye diseases like retinal drusen, retinal or optic neuropathy, or cataracts
- Use of diuretics, steroids, or other drugs affecting intracranial pressure for other conditions
- Diffuse venous sinus stenosis or cortical/deep vein stenosis on imaging
- History of severe thyroid disease or allergy to iodine
- Pregnant or breastfeeding women
- Severe heart, lung, liver, or kidney failure
- Known bleeding or clotting disorders
- Low platelet counts or coagulation abnormalities
- Major surgery, severe trauma, or brain injury within the last 14 days
- History of brain hemorrhage, arteriovenous malformation, aneurysm, or tumor
- Life-threatening illnesses likely to cause death within months or conditions affecting study follow-up
- Increased intracranial pressure due to other secondary causes
- Current intraocular pressure above 28 mmHg or prior intraocular pressure above 30 mmHg
- High refractive errors beyond allowed limits unless specific conditions met
- Large optic disc drusen causing vision loss or persistent optic disc edema unrelated to study condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
X
Xu Tong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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