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Intracranial AneurysmCOATINGNCT04870047

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

A study testing Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device in people with Intracranial Aneurysm, run by Phenox GmbH at 18 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
What is being tested?
Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
18 sitesin 7 countries
Study dates
3 Sep 2021to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age.
  • 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.
  • 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).
  • Subject has already been selected for flow diversion therapy as the appropriate treatment.
  • Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
  • 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).

Who cannot join

  • Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
  • Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
  • Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
  • Subject with target aneurysm previously treated with a stent or flow diverter.
  • Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
  • Subject with a confirmed stenosis in parent artery.
Show all 20Show fewer
  • Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
  • Subject has a pre-procedure mRS >2.
  • Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
  • Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
  • Known serious sensitivity to radiographic contrast agents.
  • Known sensitivity to nickel, titanium metals, or their alloys.
  • Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
  • Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
  • Subject who has a contraindication to MRI or angiography for whatever reason.
  • 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.
  • Subject with any known allergy to heparin, ASA or other antiplatelet medications.
  • Subject with coagulation disorder
  • Pregnant woman or breast feeding.
  • Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.

Trial locations and contacts

18 sites in 7 countries.

18 sites in 7 countries

Germany7 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Klinikum der LMU München

    München, 81377

  • Klinikum Nürnberg Süd

    Nuremberg, 90471

  • Klinikum Vest Recklinghausen

    Recklinghausen

  • Klinikum Stuttgart

    Stuttgart, 70174

Other trials in Germany

France5 sites

  • CHU Bordeaux

    Bordeaux, 33076

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHU de Lyon

    Lyon, 69002

  • CHU de Montpellier

    Montpellier, 34090

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51092

Other trials in France

United Kingdom2 sites

  • Queen Elisabeth Hospital Birmingham

    Birmingham, B15 2GW

  • Western General Hospital

    Edinburgh

Other trials in United Kingdom

Israel1 site

  • Hadassah University Medical Center

    Jerusalem, 9112001

Other trials in Israel

Italy1 site

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

    Milan, 20133

Other trials in Italy

Slovakia1 site

  • UNLP Košice

    Košice, 04190

Other trials in Slovakia

Switzerland1 site

  • Universitätsspital Basel

    Basel, 4051

Other trials in Switzerland

About this study

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

Being tested
Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation DeviceDevice

    Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

Study groups in NCT04870047
Study groupRoleWhat they receive
p64 MW HPC Flow Diverter + SAPTExperimentalNot described
Receives: Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
p64 MW Flow Diverter + DAPTExperimentalNot described
Receives: Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of DWI lesions

    Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.

    Measured: 48 hours (± 24 hours)

Secondary outcomes (13)

  1. Short-term morbi-mortality rate

    Morbi-mortality rate at 30 days assessed by mRS > 2

    Measured: 30 days (± 7 days)

  2. Rate of neurological death or major stroke

    Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  3. Long-term morbi-mortality rate

    Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  4. Rate of subjects with dissusion-weighted imaging (DWI) lesions

    Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke

    Measured: 48 hours (± 24 hours)

  5. Delayed aneurysm rupture

    Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  6. Delayed intraparenchymal hemorrhage

    Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  7. Rate of peripheral bleeding

    Rate of peripheral bleeding, as assessed by the Clinical Events Committee

    Measured: Any event reported from discharge to 365 days (335 - 456 days) post procedure

  8. Rate of device deployment at the target site without technical complications

    Rate of device deployment at the target site without technical complications, as assessed by the site

    Measured: During intervention

  9. Rate of complete aneurysm occlusion

    Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  10. Rate of target aneurysm recurrence

    Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  11. Rate of target aneurysm retreatment

    Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  12. Rate of intrastent stenosis and/or thrombosis at the target site

    Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA

    Measured: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

  13. Mean length of hospital stay

    Mean length of hospital stay (from hospital admission and up to hospital discharge)

    Measured: From admission up to discharge, assessed up to 456 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start3 Sep 2021
  3. Primary completion4 Dec 2024
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870047
Sponsor's protocol ID
CO48/BO1309
Acronym
COATING
Status last verified
Sep 2026
First submitted
26 Apr 2021
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ramirez-Velandia F, Enriquez-Marulanda A, Filo J, Young M, Fodor TB, Sconzo D, Muram S, Granstein JH, Shutran M, Taussky P, Ogilvy CS. Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score-Matched Analysis. Neurosurgery. 2024 Aug 1;95(2):330-338. doi: 10.1227/neu.0000000000002883. Epub 2024 Feb 23.

    PubMed 38391195

  • Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, Costalat V, Eker OF, Henkes H, Holtmannspotter M, Januel AC, Keston P, Klisch J, Psychogios MN, Valvassori L, Cognard C, Spelle L. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerv Surg. 2023 Jul;15(7):684-688. doi: 10.1136/neurintsurg-2022-018969. Epub 2022 May 24.

    PubMed 35609974

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device in people with Intracranial Aneurysm, run by Phenox GmbH at 18 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany, France, United Kingdom, Israel, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of DWI lesions (time frame: 48 hours (± 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04870047, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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