The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
NCT07143019 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214
Last updated 2026-05-22
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.
Conditions
- Hemorrhagic Stroke
- Aneurysm, Intracranial
- Saccular Aneurysm
- Fusiform Aneurysm
- Brain Aneurysm
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.
Sponsors & Collaborators
-
Phenox GmbH
collaborator INDUSTRY -
phenox Inc.
lead INDUSTRY
Principal Investigators
-
Demetrius Lopes, MD · Advocate Aurora Research Institute, LLC
-
Jared Knopman, MD · The Joan and Sanford I. Weill Medical College of Cornell University
-
Eytan Raz, MD · NYU Langone Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-16
- Primary Completion
- 2027-07-31
- Completion
- 2032-07-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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