Intracranial aneurysms if left untreated may continue to grow and lead to severe complications. A Flow Modulation Device is a mesh stent that is placed across the neck of the aneurysm,diverting the blood flow away from the aneurysm itself. This study will assess the safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms.
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.p48/64 MW HPC in Aneurysm Occlusion
Brain aneurysm
All genders
18+
Recruiting now
Overview
Principal Investigator: Adel Malek
Contact Us
Ashley Paro
Study details
Inclusion Criteria
- Subject has an unruptured or recanalized intracranial aneurysm.
- The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the study index procedure.
Exclusion Criteria
- Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated.
- Any other known intracranial aneurysm requiring treatment within 3 months post procedure
- Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date.
Study Requirements
- Participation of 5 years.
- Screening, Procedure, and Discharge Visits.
- In-person Follow-ups at 1 month and 6 months post procedure.
- 3 remote visits at Years 1, 3, and 5.
- Labs taken during screening.
- Angiographic imaging collected for all visits.