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

phenox

Status

Enrolling

Conditions

Intracranial Aneurysm

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04870047

CO48/BO1309

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 18 years of age.
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.
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).
Subject has already been selected for flow diversion therapy as the appropriate treatment.
Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
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

Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
Subject has undergone a surgery including endovascular procedures in the last 30 days prior 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 following the index procedure.
Subject with a confirmed stenosis in parent artery.
Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm 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 in accordance with device IFU.
Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of 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 would interfere with study endpoints.
Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular 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 and functional evaluations or compromise survival or ability to complete follow-up assessments.
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 persons deprived of their liberty in prisons or other places of detention.