Phase
Condition
Aneurysm
Treatment
Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At least 18 years of age.
- 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.
- 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).
- Subject has already been selected for flow diversion therapy as the appropriatetreatment.
- Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessorindependent of the index procedure.
- 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:
- Subject who is currently prescribed under any long lasting antiplatelet and/oranticoagulation medication.
- Subject has undergone a surgery including endovascular procedures in the last 30 daysprior to the study procedure.
- Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
- Subject with target aneurysm previously treated with a stent or flow diverter.
- Subject is expected to be treated for another aneurysm during the 30 days followingthe index procedure.
- Subject with a confirmed stenosis in parent artery.
- Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm oraneurysm associated with a brain arteriovenous malformation (AVM).
- Subject has a pre-procedure mRS >2.
- Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device inaccordance with device IFU.
- Subject who has undergone stenting of the ipsilateral carotid artery within 3 monthsof the index procedure.
- Known serious sensitivity to radiographic contrast agents.
- Known sensitivity to nickel, titanium metals, or their alloys.
- Subject already enrolled in other clinical trials (including COATING study) that wouldinterfere with study endpoints.
- Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) orglomerular filtration rate (GFR) < 30.
- Subject who has a contraindication to MRI or angiography for whatever reason.
- Subject with a comorbid disease or condition that would confound the neurological andfunctional evaluations or compromise survival or ability to complete follow-upassessments.
- Subject with any known allergy to heparin, ASA or other antiplatelet medications.
- Subject with coagulation disorder
- Pregnant woman or breast feeding.
- 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
Connect with a study center
CHU Bordeaux
Bordeaux, 33076
FranceActive - Recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
CHU de Lyon
Lyon, 69002
FranceActive - Recruiting
Marseille University Hospital Timone
Marseille, 13005
FranceSite Not Available
CHU de Montpellier
Montpellier, 34090
FranceSuspended
CHU Reims - Hôpital Maison Blanche
Reims, 51092
FranceCompleted
CHU Toulouse
Toulouse, 31059
FranceSite Not Available
Universitätsklinikum Leipzig
Leipzig, Sachsen 04103
GermanySite Not Available
Universitätsklinikum Augsburg
Augsburg, 86156
GermanySite Not Available
Helios Klinikum Erfurt
Erfurt, 99089
GermanyActive - Recruiting
Universitätsklinikum Halle (Saale)
Halle, 06120
GermanyActive - Recruiting
Klinikum der LMU München
München, 81377
GermanyActive - Recruiting
Klinikum Nürnberg Süd
Nürnberg, 90471
GermanyActive - Recruiting
Klinikum Vest Recklinghausen
Recklinghausen,
GermanyActive - Recruiting
Klinikum Stuttgart
Stuttgart, 70174
GermanyActive - Recruiting
Hadassah University Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
Milan, 20133
ItalyActive - Recruiting
Ospedale San Carlo Borromeo di Milano
Milan, 20153
ItalySite Not Available
UNLP Košice
Košice, 04190
SlovakiaActive - Recruiting
Universitätsspital Basel
Basel, 4051
SwitzerlandActive - Recruiting
Queen Elisabeth Hospital Birmingham
Birmingham, B15 2GW
United KingdomActive - Recruiting
Western General Hospital
Edinburgh,
United KingdomActive - Recruiting
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