NCT07143019

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: phenox Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC flow diverter in the treatment of wide-necked intracranial aneurysms.

Detailed description

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

Conditions

• Hemorrhagic Stroke
• Aneurysm, Intracranial
• Saccular Aneurysm
• Fusiform Aneurysm
• Brain Aneurysm

Interventions

Type	Name	Description
DEVICE	Flow diversion	The p48 MW HPC and p64 MW HPC flow modulation device is indicated for use in the treatment of intracranial aneurysms (IAs) arising from a parent vessel with a diameter of ≥2.0mm and ≤5.0 mm.

Timeline

• Start date: 2026-03-13
• Primary completion: 2027-07-01
• Completion: 2032-07-01
• First posted: 2025-08-27
• Last updated: 2026-04-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study