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

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Hemorrhagic Stroke Aneurysm, Intracranial Saccular Aneurysm Fusiform Aneurysm

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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.

Exclusion Criteria20

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.

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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.