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The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
Sponsor: 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.
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
2026-03-16
Completion Date
2032-07
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
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 (15)
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
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, 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
Stony Brook University Hospital
Stony Brook, New York, 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