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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of stent implantation compared to medical therapy in treating idiopathic intracranial hypertension (IIH) with venous sinus stenosis (VSS). This phase 3 trial is designed as a multicenter, prospective, randomized, open-label study with blinded outcome assessment. It will enroll 74 patients who have had IIH and VSS for more than two months to better understand which treatment approach may improve symptoms related to these conditions. Participants will be randomly assigned to either receive stent implantation or medical therapy. The stent procedure involves placing a self-expanding stent in the affected venous sinus under general anesthesia, preceded by medications to prevent clotting, and followed by antiplatelet treatment for several months. The medical therapy group will receive acetazolamide with dosage adjustments, short-term mannitol or lumbar punctures to reduce pressure, headache relief medications, and a weight loss program including a low-calorie diet aiming for 5-10% weight loss. During the study, participants will undergo various assessments including visual field testing, evaluation of cerebrospinal fluid pressure, eye examinations for papilledema, retinal thickness measurements, and questionnaires on visual function, headache impact, and tinnitus severity. These evaluations will occur over a six-month period to measure outcomes such as perimetric mean deviation and other vision and symptom-related changes. The trial will also monitor safety and treatment adherence throughout the study duration.
CONDITIONS
Brief Title
Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic intracranial hypertension (IIH) 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 no hydrocephalus, mass, structural lesions, or meningeal enhancement
- Localized venous sinus stenosis with 50% or greater narrowing and pressure gradient of 8 mmHg or more
- Signed informed consent by patient or relatives
- Presence of papilledema in at least one eye
- Visual field loss in at least one eye with perimetric mean deviation of -2 dB or lower and false-positive rate no more than 15%
- Visual acuity better than or equal to 20/200 (39 letters or more) in at least one eye
You will not qualify if you...
- Previous surgery for IIH such as optic nerve sheath fenestration, CSF shunting, decompressive craniectomy, or venous sinus stenting
- Rapid or progressive visual loss requiring urgent surgery
- Visual loss from other causes like retinal disease or cataracts
- Use of diuretics, steroids, or other drugs for intracranial pressure unrelated to the study
- Diffuse venous sinus stenosis or cortical/deep vein stenosis on imaging
- History of severe thyroid disease or iodine allergy
- Pregnant or breastfeeding women
- Severe heart, lung, liver, or kidney failure
- Known bleeding disorders or thrombophilia
- Abnormal platelet counts or coagulation
- Major surgery, severe trauma, or brain injury within past 14 days
- History of cerebral hemorrhage, aneurysm, arteriovenous malformation, or brain tumor
- Life-threatening illness likely to cause death soon or impair follow-up
- Increased intracranial pressure from other secondary causes
- Current eye pressure above 28 mmHg or prior pressure over 30 mmHg
- Severe refractive errors outside specified limits unless meeting specific exceptions
- Large optic disc drusen or related eye conditions affecting vision not related to IIH
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either stent implantation or medical therapy. Those in the stent implantation group undergo an endovascular procedure under general anesthesia followed by dual antiplatelet medication for 3 months, then single antiplatelet medication. Participants in the medical therapy group receive acetazolamide with dosage adjustments over about 1 week, short-term mannitol or repeated lumbar punctures to reduce intracranial pressure, analgesics for headaches, and participate in a weight loss program with a low-calorie diet.
Multiple visits as part of treatment and medication monitoring
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
X
Xu Tong, MD
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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