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New flow diverter device shows promise for brain aneurysm treatment

NCT ID NCT04034810

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study is testing the safety and effectiveness of a device called Silk Vista, used to treat brain aneurysms (a bulging blood vessel that can burst). Researchers are following 234 patients who already received the device as part of their normal care. The goal is to see how well the device works and how safe it is over time.

What this could mean

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

Active substance
Silk Vista and Silk Vista Baby flow diverter devices
What this could lead to
If successful, this could confirm that the Silk Vista device is a safe and effective option for treating brain aneurysms, potentially reducing the need for more invasive surgery.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device carries risks like any procedure, including bleeding or stroke, and long-term benefits are still being evaluated.

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 234 people

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

Started

Nov 2019

Expected to finish

Nov 2027

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

Patients with an intracranial aneurysm treated with silk vista and silk vista baby.

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: 1. Patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study) 2. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. 3. In case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit) 4. Patient ≥ 18 years, who signed an informed consent. Exclusion Criteria: 1. Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use). 2. Recanalized aneurysms initially treated with stent (including stent assisted coiling)

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

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

Flow diverter Intracranial aneurysm

Contacts and locations

Locations

  • CHC Saint Joseph Liège

    Liège, 4000, Belgium

  • CHU Caen, Radiologie interventionelle

    Caen, 14033, France

  • CHU Chalre Nicolle

    Rouen, 76000, France

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000, France

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, 37044, France

  • Centre Hospitalier Universitaire Clermont Ferrand

    Clermont-Ferrand, 63003, France

  • Centre Hospitalier Universitaire de Grenoble Alpes

    Grenoble, 38043, France

  • Chu Dupuytren Limoges

    Limoges, 87000, France

  • Cà Foncello Hospital

    Treviso, 31100, Italy

  • Fondation Rothschild

    Paris, 75019, France

  • Galilee Medical Center

    Nahariya, 22100, Israel

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hopital Cavale Blanche

    Brest, 29200, France

  • Hopsital universidad puerta de hierro

    Madrid, 28222, Spain

  • Hospices Civils de Lyon - Hôpital Neurologique

    Bron, 69677, France

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital Universitario de cruces

    Barakaldo, 48903, Spain

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Privé Clairval

    Marseille, 13009, France

  • Munich LMU University

    München, 81377, Germany

  • Niguarda Hospital

    Milan, 20162, Italy

  • Pitié-Salpêtrière Hospital

    Paris, 75651, France

  • Radboud University medical Center

    Nijmegen, 6525 G, Netherlands

  • Ramon y Cajal hospital

    Madrid, 28034, Spain

  • San Gerardo Hospital

    Monza, 20900, Italy

  • Santa maria della misericordia hospital

    Udine, 33100, Italy

  • University Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Universitätsklinik für Neurologie

    Salzburg, A-5020, Austria

  • Unversitario Central de Asturias

    Oviedo, 33011, Spain

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