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

Recruiting now · Not applicable

Conditions studied: Hemorrhagic Stroke, Aneurysm, Intracranial, Saccular Aneurysm, Fusiform Aneurysm, Brain Aneurysm

In brief

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.

Key facts

Study ID

NCT07143019

Run by

phenox Inc.

People needed

214

Starts

2026-03-16

Expected to finish

2032-07-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years
• Subject has a mRS ≤2 before the index procedure
• Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:
• Saccular or fusiform morphology
• Located in the internal carotid artery and its branches
• Aneurysm neck ≥4 mm or dome-to-neck ratio <2
• Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
• Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.

You may not qualify if…

• Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
• Any other known IA requiring treatment within 3 months post-procedure
• Subarachnoid hemorrhage in the past 30 days prior to the index procedure
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
• Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure
• Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
• Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
• Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
• Known serious sensitivity to radiographic contrast agents that cannot be managed medically
• Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
• Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
• Known renal failure with a serum creatinine >2.5 mg/dl (or 220 μmol/l) not on dialysis
• Contraindication to CT scan, MRI, or angiography
• Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
• Known coagulopathy, or an admission International Normalized Ratio >3.0 without oral anticoagulation therapy, or an admission platelet count of <100000
• Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
• Unable to complete the required study follow-ups
• Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
• Participating in another clinical trial that could affect participation or primary outcomes of this study
• Women currently pregnant or wish to become pregnant during the study or breast feeding.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
• UCSF Medical Center — San Francisco, California, United States (enrolling)
• University of Colorado Anschutz — Aurora, Colorado, United States (enrolling)
• Swedish Medical Research Center — Englewood, Colorado, United States (enrolling)
• Baptist Health Research Institute — Jacksonville, Florida, United States (enrolling)
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States (enrolling)
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• WashU Medicine — St Louis, Missouri, United States (enrolling)
• UBNS — Buffalo, New York, United States (enrolling)
• North Shore University Hospital - Northwell Health — Manhasset, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• NewYork-Presbyterian / Weill Cornell Medical Center — New York, New York, United States (enrolling)
• Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
• East Carolina University Health Medical Center — Greenville, North Carolina, United States (enrolling)
• The University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Washington - Harborview Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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