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

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: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Demant-Bauchspiess; Phone Number: +49 (0)173 3099117; Email: COATING@wallabyphenox.com
• Study Contact Backup: Name: Katarzyna Dudar; Phone Number: 1744 +49 234 36 919; Email: COATING@wallabyphenox.com

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • CHU Bordeaux
    • Contact: Xavier Barreau, Dr.
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Hôpital Bicêtre
    • Contact: Laurent Spelle, Prof.
  • Lyon, France, 69002
    • Recruiting
    • Chu de Lyon
    • Contact: Omer Eker, Prof.
  • Marseille, France, 13005
    • Not yet recruiting
    • Marseille University Hospital Timone
    • Contact: Jean-François Hak, Dr.
  • Montpellier, France, 34090
    • Suspended
    • CHU de Montpellier
  • Reims, France, 51092
    • Completed
    • CHU Reims - Hôpital Maison Blanche
  • Toulouse, France, 31059
    • Withdrawn
    • CHU Toulouse
• Germany
  • Augsburg, Germany, 86156
    • Active, not recruiting
    • Universitatsklinikum Augsburg
  • Erfurt, Germany, 99089
    • Recruiting
    • Helios Klinikum Erfurt
    • Contact: Joachim Klisch, Prof.
  • Halle, Germany, 06120
    • Recruiting
    • Universitatsklinikum Halle (Saale)
    • Contact: Stefan Schob, Dr. med.
  • München, Germany, 81377
    • Recruiting
    • Klinikum der LMU München
    • Contact: Thomas Liebig, Prof. Dr.
  • Nürnberg, Germany, 90471
    • Recruiting
    • Klinikum Nürnberg Süd
    • Contact: Markus Holtmannspötter, Dr.
  • Recklinghausen, Germany
    • Recruiting
    • Klinikum Vest Recklinghausen
    • Contact: Christian Loehr, Dr. med.
  • Stuttgart, Germany, 70174
    • Recruiting
    • Klinikum Stuttgart
    • Contact: Victoria Hellstern, Dr.
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Withdrawn
      • Universitatsklinikum Leipzig
• Israel
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah University Medical Center
    • Contact: Jose Cohen, Dr.
• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
    • Contact: Elisa Francesca Maria Ciceri, Dr.
• Slovakia
  • Košice, Slovakia, 04190
    • Recruiting
    • UNLP Košice
    • Contact: Piotr Pedowski, MUDr.
• Switzerland
  • Basel, Switzerland, 4051
    • Recruiting
    • Universitatsspital Basel
    • Contact: Marios-Nikos Psychogios, Prof. Dr.
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Recruiting
    • Queen Elisabeth Hospital Birmingham
    • Contact: Saleh Lamin, Dr.
  • Edinburgh, United Kingdom
    • Recruiting
    • Western General Hospital
    • Contact: Peter Keston, Dr.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Morbi-mortality rate at 30 days assessed by mRS > 2	30 days (± 7 days)
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	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
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	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of subjects with dissusion-weighted imaging (DWI) lesions	Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke	48 hours (± 24 hours)
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	180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Delayed intraparenchymal hemorrhage	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	Rate of device deployment at the target site without technical complications, as assessed by the site	During intervention
Rate of complete aneurysm occlusion	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	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	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	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	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	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

• Sponsor: Phenox GmbH
• Investigators: Principal Investigator: Laurent Pierot, Prof. Dr., CHRU Hôpital Maison-Blanche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

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): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• 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