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Special coating on brain stent may reduce dangerous narrowing

NCT ID NCT07420179

Disease control Sponsor: Universität des Saarlandes 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a coated stent (Derivo 2 heal) causes less narrowing inside the artery than an uncoated stent after treating brain aneurysms. 21 adults with unruptured aneurysms in the internal carotid artery were randomly assigned to receive one of the two stents. Researchers measured narrowing on follow-up scans at 3 and 9 months to see if the coating helps keep the artery open.

What this could mean

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

Active substance
Coated flow diverter stent (Derivo 2 heal)
What this could lead to
If the coated stent reduces narrowing, it could improve long-term outcomes for people with brain aneurysms treated with stents.
What could go wrong
This is a very small study (21 people) and only looks at a specific type of aneurysm. Results may not apply to all patients or show clear benefits.

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

21 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2025

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 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: * Adults aged ≥18 years * Unruptured, saccular aneurysm of the internal carotid artery (ICA) suitable for single-device flow diverter treatment * Availability of angiographic follow-up imaging at both 3 and 9 months Exclusion Criteria: * Fusiform or dissecting aneurysms * Requirement for multiple flow diverter implantation * Previous treatment of the target aneurysm * Contraindications to dual antiplatelet therapy

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm

As listed by the trial registrant

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

Aneurysm cerebral

Contacts and locations

Locations

  • Saarland University Hospital

    Homburg, Saarland, 66421, Germany

More trials for these conditions

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