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10,000-Patient study monitors BALT medical devices in Real-World use

NCT ID NCT04927156

Knowledge-focused Sponsor: Balt Extrusion Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is collecting information from up to 10,000 people who receive BALT medical devices for conditions like brain aneurysms, stroke, and blocked arteries. Researchers will track how well the devices work and if any safety issues arise during routine care. The goal is to gather real-world data to confirm the devices perform as expected.

What this could mean

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

What this could lead to
If successful, this study will provide real-world evidence on the safety and performance of BALT devices, helping doctors choose the best treatments for vascular conditions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care across hospitals.

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.

Participants

About 10,000 people

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

Started

Jul 2021

Expected to finish

Oct 2041

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.

Who is studied

The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.

Ages

2 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: * Provision of a signed, written and dated informed consent or non-opposition (where applicable) Exclusion Criteria * Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure) * Contra-indications of each device as described in the instructions for use.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

arteriovenous malformations of the brain brain aneurysm cerebral arterial disease congenital arteriovenous fistula intracranial arterial disease ischemic stroke peripheral vascular disease

As listed by the trial registrant

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

Acute ischemic stroke AVM Avm - cerebral arteriovenous malformation Brain arterial disease Fistulas arteriovenous Intracranial aneurysm Peripheral vascular diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 3 countries. 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

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Grenoble Alpes

    RECRUITING

    La Tronche, France

  • Chu Bordeaux

    RECRUITING

    Bordeaux, France

  • Chu Tours

    RECRUITING

    Tours, 37000, France

  • Halle

    RECRUITING

    Halle, Germany

  • Hospital Clinico Universitario San Carlos

    TERMINATED

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla (HUMV)

    RECRUITING

    Santander, Spain

  • Hospital Universitario Miguel Servet

    NOT_YET_RECRUITING

    Zaragoza, Spain

  • Hospital: Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28222, Spain

  • Hôpital Roger Salengro

    RECRUITING

    Lille, France

  • Kremlin Bicêtre - APHP

    RECRUITING

    Paris, France

  • Unversitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

More trials for these conditions

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