Stent or pill? new trial tackles pressure in the brain
NCT ID NCT05707442
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether placing a small tube (stent) in a narrowed brain vein works better than standard medication for people with idiopathic intracranial hypertension (high pressure in the brain). About 74 adults with this condition and a narrowed vein will be randomly assigned to get a stent or continue medical therapy. The main goal is to see which approach better improves vision and reduces pressure after 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject Eligibility Criteria 1. Diagnosis of IIH by modified Dandy criteria about for more than 2 months 2. Lumbar puncture opening pressure ≥250 mmH₂O within 6 weeks before enrollment 3. Normal cerebrospinal fluid (CSF) composition 4. Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI 5. Localized venous sinus stenosis (VSS) with stenotic degree ≥ 50% on DSA, and pressure gradient across stenosis ≥ 8 mmHg 6. Patients or their relatives signed written informed consent * Ophthalmic Eligibility Criteria: 1. At least one eye had the presence of papilledema 2. 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% 3. Visual acuity above 20 / 200 (≥ 39 letters) Exclusion Criteria: * Subject Exclusion Criteria 1. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting 2. 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 3. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc) 4. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure 5. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis 6. A history of severe thyroid disease and iodine allergy 7. Pregnant or lactating women 8. Severe cardiopulmonary, liver or kidney failure 9. Known hereditary or acquired haemorrhagic diathesis 10. Known hereditary or acquired thrombophilia 11. Platelet counts or coagulation abnormality 12. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days 13. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor 14. 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 15. Increased intracranial pressure due to other secondary factors * Ophthalmic Exclusion Criteria: 1. Current intraocular pressure \> 28mmHg or previous intraocular pressure \> 30mmHg 2. Refractive error spherical power greater than -6.0D or +6.0D and astigmatism greater than 3.0D, except for the following cases: 1. 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. 2. 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. 3. 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital
RECRUITINGBeijing, Beijing Municipality, 100010, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.