Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation (COATING)

September 15, 2026 updated by: Phenox GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU Bordeaux
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Lyon, France, 69002
        • CHU de Lyon
      • Montpellier, France, 34090
        • CHU de Montpellier
      • Reims, France, 51092
        • CHU Reims - Hôpital Maison Blanche
  • Germany
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale)
      • München, Germany, 81377
        • Klinikum der LMU München
      • Nuremberg, Germany, 90471
        • Klinikum Nürnberg Süd
      • Recklinghausen, Germany
        • Klinikum Vest Recklinghausen
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah University Medical Center
  • Italy
      • Milan, Italy, 20133
        • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
  • Slovakia
      • Košice, Slovakia, 04190
        • UNLP Košice
  • Switzerland
      • Basel, Switzerland, 4051
        • Universitätsspital Basel
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elisabeth Hospital Birmingham
      • Edinburgh, United Kingdom
        • Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: p64 MW HPC Flow Diverter + SAPT
Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.
Experimental: p64 MW Flow Diverter + DAPT
Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of DWI lesions
Time Frame: 48 hours (± 24 hours)
Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.
48 hours (± 24 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term morbi-mortality rate
Time Frame: 30 days (± 7 days)
Morbi-mortality rate at 30 days assessed by mRS > 2
30 days (± 7 days)
Rate of neurological death or major stroke
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Long-term morbi-mortality rate
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of subjects with dissusion-weighted imaging (DWI) lesions
Time Frame: 48 hours (± 24 hours)
Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke
48 hours (± 24 hours)
Delayed aneurysm rupture
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Delayed intraparenchymal hemorrhage
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of device deployment at the target site without technical complications
Time Frame: During intervention
Rate of device deployment at the target site without technical complications, as assessed by the site
During intervention
Rate of complete aneurysm occlusion
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm recurrence
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm retreatment
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of intrastent stenosis and/or thrombosis at the target site
Time Frame: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Mean length of hospital stay
Time Frame: From admission up to discharge, assessed up to 456 days
Mean length of hospital stay (from hospital admission and up to hospital discharge)
From admission up to discharge, assessed up to 456 days
Rate of peripheral bleeding
Time Frame: Any event reported from discharge to 365 days (335 - 456 days) post procedure
Rate of peripheral bleeding, as assessed by the Clinical Events Committee
Any event reported from discharge to 365 days (335 - 456 days) post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phenox GmbH

Investigators

  • Principal Investigator: Laurent Pierot, Prof. Dr., CHRU Hôpital Maison-Blanche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2021

Primary Completion (Actual)

December 4, 2024

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO48/BO1309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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