The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms

Prior treatment

• Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
• Subarachnoid hemorrhage in the past 30 days prior to the index procedure
• Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure
• Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
• Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components

Other illness

• Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
• Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
• Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
• Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial

Lab values

• Known renal failure with a serum creatinine \>2.5 mg/dl (or 220 μmol/l) not on dialysis
• Known coagulopathy, or an admission International Normalized Ratio \>3.0 without oral anticoagulation therapy, or an admission platelet count of \<100000
• Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)

Other

• Any other known IA requiring treatment within 3 months post-procedure
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
• Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
• Known serious sensitivity to radiographic contrast agents that cannot be managed medically
• Contraindication to CT scan, MRI, or angiography
• Unable to complete the required study follow-ups
• Participating in another clinical trial that could affect participation or primary outcomes of this study
• Women currently pregnant or wish to become pregnant during the study or breast feeding.

• Subject is ≥ 18 years
• Subject has a mRS ≤2 before the index procedure
• Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:
  • Saccular or fusiform morphology
  • Located in the internal carotid artery and its branches
  • Aneurysm neck ≥4 mm or dome-to-neck ratio \<2
  • Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
• Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.