Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Last updated: March 12, 2024
Sponsor: Phenox GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

Clinical Study ID

NCT04870047
CO48/BO1309
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age.
  2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subjectmay also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 daysfrom the index procedure.
  3. Subject is intended to be treated for only one target aneurysm during the indexprocedure except for segmental disease (multiple aneurysms located on the samearterial segment aimed to be treated with one investigational device orinvestigational telescopic devices).
  4. Subject has already been selected for flow diversion therapy as the appropriatetreatment.
  5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessorindependent of the index procedure.
  6. Subject is able to understand the patient information and provides written informedconsent verifying the use of his/her data (according to data protection laws).

Exclusion

Exclusion Criteria:

  1. Subject who is currently prescribed under any long lasting antiplatelet and/oranticoagulation medication.
  2. Subject has undergone a surgery including endovascular procedures in the last 30 daysprior 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 followingthe index procedure.
  6. Subject with a confirmed stenosis in parent artery.
  7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm oraneurysm 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 inaccordance with device IFU.
  10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 monthsof 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 wouldinterfere with study endpoints.
  14. Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) orglomerular 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 andfunctional evaluations or compromise survival or ability to complete follow-upassessments.
  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 personsdeprived of their liberty in prisons or other places of detention.

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Phase:
Study Start date:
September 03, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Active - Recruiting

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • CHU de Lyon

    Lyon, 69002
    France

    Active - Recruiting

  • Marseille University Hospital Timone

    Marseille, 13005
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34090
    France

    Suspended

  • CHU Reims - Hôpital Maison Blanche

    Reims, 51092
    France

    Completed

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt, 99089
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Active - Recruiting

  • Klinikum der LMU München

    München, 81377
    Germany

    Active - Recruiting

  • Klinikum Nürnberg Süd

    Nürnberg, 90471
    Germany

    Active - Recruiting

  • Klinikum Vest Recklinghausen

    Recklinghausen,
    Germany

    Active - Recruiting

  • Klinikum Stuttgart

    Stuttgart, 70174
    Germany

    Active - Recruiting

  • Hadassah University Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

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

    Milan, 20133
    Italy

    Active - Recruiting

  • Ospedale San Carlo Borromeo di Milano

    Milan, 20153
    Italy

    Site Not Available

  • UNLP Košice

    Košice, 04190
    Slovakia

    Active - Recruiting

  • Universitätsspital Basel

    Basel, 4051
    Switzerland

    Active - Recruiting

  • Queen Elisabeth Hospital Birmingham

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Western General Hospital

    Edinburgh,
    United Kingdom

    Active - Recruiting

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