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

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ClinicalTrials.gov Identifier: NCT04870047
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Phenox GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Short-term morbi-mortality rate [ Time Frame: 30 days (± 7 days) ]
    Morbi-mortality rate at 30 days assessed by mRS > 2

  2. Rate of neurological death or major stroke [ Time Frame: 180 days (± 30 days) and 365 days (± 30 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

  3. Long-term morbi-mortality rate [ Time Frame: 180 days (± 30 days) and 365 days (± 30 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

  4. 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

  5. Delayed aneurysm rupture [ Time Frame: 180 days (± 30 days) and 365 days (± 30 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

  6. Delayed intraparenchymal hemorrhage [ Time Frame: 180 days (± 30 days) and 365 days (± 30 days) post procedure ]
    Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee

  7. 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

  8. Rate of complete aneurysm occlusion [ Time Frame: 180 days (± 30 days) and 365 days (± 30 days) post procedure ]
    Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab

  9. Rate of target aneurysm recurrence [ Time Frame: 180 days (± 30 days) and 365 days (± 30 days) post procedure ]
    Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab

  10. Rate of target aneurysm retreatment [ Time Frame: 180 days (± 30 days) and 365 days (± 30 days) post procedure ]
    Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee

  11. Rate of intrastent stenosis and/or thrombosis at the target site [ Time Frame: 180 days (± 30 days) and 365 days (± 30 days) post procedure ]
    Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA

  12. Mean length of hospital stay [ Time Frame: Up to Discharge (up to 3 days post procedure) ]
    Mean length of hospital stay (from hospital admission and up to hospital discharge) post index procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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. Pregnant woman or breast feeding.
  19. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870047


Contacts
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Contact: Sabine Konopka +49 234 36919 ext 0 COATING@phenox.info
Contact: Lena Oettinghaus +49 234 36919 ext 0 COATING@phenox.info

Locations
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France
CHU Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Xavier Barreau, Dr.         
Hôpital Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Laurent Spelle, Prof.         
CHU de Lyon Recruiting
Lyon, France, 69002
Contact: Omer Eker, Prof.         
CHU de Montpellier Not yet recruiting
Montpellier, France, 34090
Contact: Vincent Costalat, Prof.         
CHU Reims - Hôpital Maison Blanche Recruiting
Reims, France, 51092
Contact: Laurent Pierot, Prof.         
CHU Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Christophe Cognard, Prof.         
Sponsors and Collaborators
Phenox GmbH
Investigators
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Principal Investigator: Laurent Pierot, Prof. Dr. CHRU Hôpital Maison-Blanche
More Information
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Responsible Party: Phenox GmbH
ClinicalTrials.gov Identifier: NCT04870047    
Other Study ID Numbers: CO48/BO1309
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases