NCT07143019 · phenox Inc.
The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms
(PIANO)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Phoenix, Arizona
- San Francisco, California
- Aurora, Colorado
- Englewood, Colorado
- Jacksonville, Florida
- Atlanta, Georgia
- Park Ridge, Illinois
- Iowa City, Iowa
- Boston, Massachusetts
- St Louis, Missouri
- Buffalo, New York
- Manhasset, New York
And 8 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations