Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
NCT ID: NCT04870047
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
171 participants
INTERVENTIONAL
2021-09-03
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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p64 MW HPC Flow Diverter + SAPT
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.
p64 MW Flow Diverter + DAPT
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Phenox GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Laurent Pierot, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
CHRU Hôpital Maison-Blanche
Locations
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CHU Bordeaux
Bordeaux, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHU de Lyon
Lyon, , France
CHU de Montpellier
Montpellier, , France
CHU Reims - Hôpital Maison Blanche
Reims, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Universitätsklinikum Halle (Saale)
Halle, , Germany
Klinikum der LMU München
München, , Germany
Klinikum Nürnberg Süd
Nuremberg, , Germany
Klinikum Vest Recklinghausen
Recklinghausen, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
Hadassah University Medical Center
Jerusalem, , Israel
Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
Milan, , Italy
UNLP Košice
Košice, , Slovakia
Universitätsspital Basel
Basel, , Switzerland
Queen Elisabeth Hospital Birmingham
Birmingham, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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CO48/BO1309
Identifier Type: -
Identifier Source: org_study_id
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