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New device aims to seal brain aneurysms without surgery

NCT ID NCT04380350

Disease control Sponsor: Stryker Neurovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called Trenza for treating brain aneurysms. It involved 150 people aged 18 to 80 with a single saccular aneurysm between 6 and 12 mm. The goal was to see if the device could safely block the aneurysm from blood flow and prevent strokes.

What this could mean

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

Active substance
Trenza embolization device
What this could lead to
If it works, this device could offer a safe and effective way to treat brain aneurysms without open surgery.
What could go wrong
This is a post-market study, so the device is already approved. However, risks include stroke or incomplete aneurysm sealing.

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

150 people

The number who actually took part.

Started

Dec 2020

Finished

Feb 2026

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 treated with Trenza device

Ages

18 to 80 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: 1. Age is ≥18 and ≤80 years 2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment (Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days). 3. Aneurysm morphology is saccular 4. Aneurysm size is between 6-12 mm 5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm 6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2. 7. Must be willing to comply with protocol required procedures and follow up 8. Must be willing to sign and date an Ethics Committee approved written informed consent prior to initiation of any screening or study procedures 9. Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures Exclusion Criteria: 1. Target aneurysm has been previously treated. 2. Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm. 3. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm. 4. Treatment with flow diverting stent implant is anticipated. 5. A planned, staged procedure is anticipated. 6. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery. 7. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage. 8. Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable) 9. Has a known coagulopathy or is on chronic anticoagulant therapy. 10. Is pregnant or intends to become pregnant during the study or is breastfeeding. 11. Is concurrently involved in another study that could affect outcomes of IA treatment. 12. Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years. 13. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure. 14. Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.

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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 Intracranial aneurysm

Contacts and locations

Locations

  • APHP Bicêtre

    Paris, France

  • Asklepios Hospital Hamburg St. Georg

    Hamburg, Germany

  • Besta hopsital

    Milan, Italy

  • Bordeaux Hopsital

    Bordeaux, France

  • Brest Hospital

    Brest, France

  • HCL Lyon

    Lyon, France

  • Helsinski University Hospital

    Helsinki, Finland

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Spain

  • Hospital Universitario 12 de octubre

    Madrid, Spain

  • Montpellier Hospital

    Montpellier, France

  • NHS Lothian

    Edinburgh, United Kingdom

  • Purpan Hospital

    Toulouse, France

  • Queen Elizabeth Hospital Birmingham

    Birmingham, United Kingdom

  • Queen Elizabeth University Hospital

    Glasgow, United Kingdom

  • Salzburg University Hopsital

    Salzburg, Austria

  • Turun yliopistollinen keskussairaala

    Turku, Finland

  • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

    Bochum, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, Germany

More trials for these conditions

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