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Coated stent aims to cut blood thinner needs for brain aneurysms

NCT ID NCT04870047

Disease control Sponsor: Phenox 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers compare two versions of a mesh stent used to treat unruptured brain aneurysms. One version has a special coating and is paired with a single blood-thinning drug; the other is the standard device paired with two blood-thinning drugs. The trial measures tiny brain lesions on MRI scans after the procedure and tracks stroke and death rates at 30 days. Adults with a saccular, unruptured, or recanalized intracranial aneurysm can join.

What this could mean

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

Active substance
p64 MW HPC Flow Modulation Device, a coated mesh stent that redirects blood flow away from a brain aneurysm
What this could lead to
If the coated device works, people with unruptured brain aneurysms might need only one blood-thinning drug instead of two, which could lower bleeding risks.
What could go wrong
The trial may show the coated device does not reduce small brain lesions or complications compared with the standard device. Single antiplatelet therapy carries its own risk of clot formation, and results may not apply to all aneurysm types.

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

171 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2025

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: 1. At least 18 years of age. 2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure. 3. Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices). 4. Subject has already been selected for flow diversion therapy as the appropriate treatment. 5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure. 6. Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws). Exclusion Criteria: 1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication. 2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure. 3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure. 4. Subject with target aneurysm previously treated with a stent or flow diverter. 5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure. 6. Subject with a confirmed stenosis in parent artery. 7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM). 8. Subject has a pre-procedure mRS \>2. 9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU. 10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure. 11. Known serious sensitivity to radiographic contrast agents. 12. Known sensitivity to nickel, titanium metals, or their alloys. 13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints. 14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30. 15. Subject who has a contraindication to MRI or angiography for whatever reason. 16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments. 17. Subject with any known allergy to heparin, ASA or other antiplatelet medications. 18. Subject with coagulation disorder 19. Pregnant woman or breast feeding. 20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.

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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.

Intracranial aneurysm

Contacts and locations

Locations

  • CHU Bordeaux

    Bordeaux, 33076, France

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51092, France

  • CHU de Lyon

    Lyon, 69002, France

  • CHU de Montpellier

    Montpellier, 34090, France

  • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Hadassah University Medical Center

    Jerusalem, 9112001, Israel

  • Helios Klinikum Erfurt

    Erfurt, 99089, Germany

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Klinikum Nürnberg Süd

    Nuremberg, 90471, Germany

  • Klinikum Stuttgart

    Stuttgart, 70174, Germany

  • Klinikum Vest Recklinghausen

    Recklinghausen, Germany

  • Klinikum der LMU München

    München, 81377, Germany

  • Queen Elisabeth Hospital Birmingham

    Birmingham, B15 2GW, United Kingdom

  • UNLP Košice

    Košice, 04190, Slovakia

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitätsspital Basel

    Basel, 4051, Switzerland

  • Western General Hospital

    Edinburgh, United Kingdom

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