RecruitingNot ApplicableNCT07143019

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.

Sponsor

phenox Inc.

Enrollment

214 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Hemorrhagic Stroke Aneurysm, Intracranial Saccular Aneurysm Fusiform Aneurysm Brain aneurysm

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Flow diversion for people with aneurysm, intracranial, brain aneurysm, and other related conditions. The study is currently recruiting participants at 21 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFlow 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(21)

Barrow Neurological Institute

Phoenix, Arizona, United States

UCSF Medical Center

San Francisco, California, 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

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Tufts Medical Center

Boston, Massachusetts, United States

WashU Medicine

St Louis, Missouri, United States

UBNS

Buffalo, New York, United States

North Shore University Hospital - Northwell Health

Manhasset, New York, United States

NYU Langone Health

New York, New York, United States

NewYork-Presbyterian / Weill Cornell Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

East Carolina University Health Medical Center

Greenville, North Carolina, United States

The University of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Washington - Harborview Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07143019

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