Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

Launched by PHENOX GMBH · Apr 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the p64 MW HPC Flow Modulation Device, which is being tested for treating a type of brain condition known as an intracranial aneurysm. The trial aims to see how safe and effective this device is when patients are given either one type of blood thinner (single antiplatelet therapy) or two types (dual antiplatelet therapy) before and after the procedure. People aged 18 and older who have an unruptured aneurysm or a previously treated one may be eligible to participate, as long as they have not had recent surgeries or other specific medical conditions that could complicate their treatment.

If you decide to join the trial, you will receive the flow diverter device as part of your treatment, and doctors will carefully monitor your health throughout the study. It's important for participants to understand what their involvement entails, including providing consent for their data to be used. This trial is currently recruiting, meaning they are looking for participants to help in understanding how this new device can improve treatment for people with aneurysms.

Gender

ALL

Eligibility 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 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:
• • 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. 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.