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

p48/64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.

To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.

To assess safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.

Inclusion Criteria:

1. Subject is ≥ 18 years

2. Subject has a mRS ≤2 before the index procedure

3. 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:

   1. Saccular or fusiform morphology
   2. Located in the internal carotid artery and its branches
   3. Aneurysm neck ≥4 mm or dome-to-neck ratio <2
   4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA

4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.

Exclusion Criteria:

1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
2. Any other known IA requiring treatment within 3 months post-procedure
3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure
4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
5. 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
6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically
10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
11. Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
12. Known renal failure with a serum creatinine >2.5 mg/dl (or 220 μmol/l) not on dialysis
13. Contraindication to CT scan, MRI, or angiography
14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
15. Known coagulopathy, or an admission International Normalized Ratio >3.0 without oral anticoagulation therapy, or an admission platelet count of <100000
16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
17. Unable to complete the required study follow-ups
18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
19. Participating in another clinical trial that could affect participation or primary outcomes of this study
20. Women currently pregnant or wish to become pregnant during the study or breast feeding.