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RECRUITING
NCT07143019
NA

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

Sponsor: phenox Inc.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2026-02

Completion Date

2032-06

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

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.

Locations (8)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Colorado Anschutz

Aurora, Colorado, United States

Swedish Medical Research Center

Englewood, Colorado, United States

Baptist Health Research Institute

Jacksonville, Florida, United States

Tufts Medical Center

Boston, Massachusetts, United States

UBNS

Buffalo, New York, United States

North Shore University Hospital - Northwell Health

Manhasset, New York, United States

University of Washington - Harborview Medical Center

Seattle, Washington, United States