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Brain stent trial aims to ease pressure headaches and save sight

NCT ID NCT07561268

Disease control Sponsor: Acandis GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new stent called SILANCE for people with idiopathic intracranial hypertension (IIH), a condition where high pressure inside the skull causes severe headaches, ringing in the ears, and vision problems. The stent is placed in a narrowed vein in the brain to improve blood flow and lower pressure. The study will enroll 99 participants and follow them for 12 months to see if symptoms improve and if the procedure is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SILANCE stent (a laser-cut, self-expanding metal tube placed in a narrowed brain vein)
What this could lead to
If it works, this could offer a new treatment option for people with IIH whose symptoms are not controlled by standard care, potentially reducing headaches, ringing in the ears, and vision loss.
What could go wrong
This is an early-stage, non-randomized trial with no control group, so results may not apply to all IIH patients. Risks include stroke, stent blockage, or the stent moving out of place.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 99 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Diagnosis of idiopathic intracranial hypertension (IIH) according to the Modified Dandy Criteria. * Cerebrospinal fluid (CSF) lumbar puncture opening pressure \> 25 cm H₂O. * Presence of lateral venous sinus stenosis confirmed by venous magnetic resonance angiography (MRA) or venous computed tomography angiography (CTA). * Presence of clinical symptoms consistent with IIH, including headaches, visual field loss, papilledema or pulsatile tinnitus. * Venous pressure gradient across the stenosis \> 3 mmHg under general anaesthesia, \> 4 mmHg under local anaesthesia. * Temporal Bone CT done for Patients suffering from Pulsatile Tinnitus * Written informed consent obtained prior to any study-related procedures.

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Conditions

The condition(s) this trial relates to.

pseudotumor cerebri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic intracranial hypertension (IIH)

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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 ↗

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Contacts and locations

Study contacts

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