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.
phenox Inc.
Summary
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No