Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Stent or pill? new trial tackles pressure in the brain

NCT ID NCT05707442

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Idiopathic intracranial hypotension are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Tiantan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100010, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.