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Hemorrhagic StrokePIANONCT07143019

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

A study testing Flow diversion in people with Hemorrhagic Stroke and Aneurysm, Intracranial, run by phenox Inc. at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Flow diversion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
25 sitesUnited States
Study dates
16 Mar 2026to Jul 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mairéad Cleary contact

+353 91 740 100

mairead.cleary@wallabyphenox.com

Nguyet T Labenski contact

nguyet.labenski@wallabyphenox.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

    Shardae Shavers, 404-605-2277, Shardae.Shavers@piedmont.org

    Michael F Stiefel, MD, PhD

    Recruiting

  • University of Colorado Anschutz

    Aurora, Colorado, 80045

    Jennifer Maitlen, RN, BSN, 303-724-1995, jennifer.maitlen@cuanschutz.edu

    Joshua Seinfeld, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Ashley Paro, 617-636-5000, Ashley.Paro@tuftsmedicine.org

    Adel Malek, MD

    Recruiting

  • UBNS

    Buffalo, New York, 14203

    Michaela Laskowski, mlaskowski@ubns.com

    Ellen Carl, ecarl@ubns.com

    Recruiting

  • Northwestern Medicine

    Chicago, Illinois, 60611

    Pouya Nazari, 312-695-9014, pouya.nazari@nm.org

    Matthew B Potts, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Tyfe Oderinde, MS, 214-648-9905, Bolutyfe.Oderinde@UTSouthwestern.edu

    Panagiotis Mastorakos, MD, PhD

    Recruiting

  • Swedish Medical Research Center

    Englewood, Colorado, 80113

    Ashley Thompson, 303-907-5634, Ashley.Thompson3@HCAhealthcare.com

    Don Frei, MD

    Recruiting

  • East Carolina University Health Medical Center

    Greenville, North Carolina, 27834

    Miriam Wood, MPH, 252-744-5696, miriam.wood@ecuhealth.org

    Richard T Dalyai, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Julia Ivey, julia-ivey@uiowa.edu

    Daniel F Waldschmidt, daniel-waldschmidt@uiowa.edu

    Recruiting

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

    Dollie Jennings, Ph.D, 904-202-7063, Sarah.Jennings@bmcjax.com

    Eric Sauvageau, MD

    Recruiting

  • University of Southern California Health Sciences / Keck Hospital of USC

    Los Angeles, California, 90033

    Kelly Hu, 323-442-0661, Kelly.Hu@med.usc.edu

    Rosalina Mayorga, DrPH, MPH, CHES, Rosalina.Mayorga@med.usc.edu

    Recruiting

  • North Shore University Hospital - Northwell Health

    Manhasset, New York, 11030

    Betsy Moclair, RN, MBA,CCRC, 917-673-4908, bmoclair@northwell.edu

    Athos Patsalides, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Morgan Mohler, 615-421-1507, morgan.mohler@vumc.org

    Rohan Chitale, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Maria Fabal, 212-263-1004, Maria.Fabal@nyulangone.org

    Eytan Raz, MD, PhD

    Recruiting

  • NewYork-Presbyterian / Weill Cornell Medical Center

    New York, New York, 10065

    Jackson Hagen, 913-953-6961, jrh4002@med.cornell.edu

    Hanah Hwang, hah4023@med.cornell.edu

    Recruiting

  • The University of Oklahoma

    Oklahoma City, Oklahoma, 73104

    Sanaa Hameed, 405-271-8001 ext. 32268, Sanaa-Hameed@ouhsc.edu

    Michael Omini, Michael-Omini@ou.edu

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Victor Arroyo, Arroyo, 847-723-7950 ext. 217950, victor.arroyo@aah.org

    Kathleen Hesse, BA, RN, CCRC, 708-684-4690 ext. 41-4690, Kathleen.Hesse@aah.org

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sophia Bautista, 215-906-4165, sophia.bautista@pennmedicine.upenn.edu

    Jan-Karl Burkhardt, MD

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

    Alex Reynolds, 602-406-6227, alex.reynolds@commonspirit.org

    Andrew Ducruet, MD

    Recruiting

  • Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center

    Portland, Oregon, 97239

    Emma Blackburn, blackbue@ohsu.edu

    Ryan A Priest, MD

    Recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84132

    Heather A Meyer, 801-587-2924, heather.a.meyer@hsc.utah.edu

    Craig Kilburg, MD

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Atakan Orscelik, MD, 415-353-7500, atakan.orscelik@ucsf.edu

    Diana Flores, 415-514-8987, diana.flores@ucsf.edu

    Recruiting

  • University of Washington - Harborview Medical Center

    Seattle, Washington, 98104

    Tyler Ip, 206-744-9389, siutai@uw.edu

    Michael Levitt, MD

    Recruiting

  • WashU Medicine

    St Louis, Missouri, 63110

    Ramie Heo, 314-747-4569, heor@wustl.edu

    Joshua W Osbun, MD, FACS, FAHA

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Marlene Baumeister, RN, BSN, CCRC, CNRN, 631-444-1610, Marlene.Baumeister@stonybrookmedicine.edu

    Dawn Madigan, RN, BSN,CCRC, Dawn.Madigan@stonybrookmedicine.edu

    Recruiting

Other trials in United States

About this study

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.

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.

Read the detailed description

To assess safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.

Being tested
Flow diversion
Keywords
Neurovascular Intervention, phenox, Brain, Unruptured Aneurysm, Flow diversion, Flow diverter, Occlusion, Flow modulation device
Medical subject headings
Hemorrhagic Stroke, Intracranial Aneurysm, Aneurysm, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flow diversionDevice

    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.

Study groups in NCT07143019
Study groupRoleWhat they receive
Intervention/TreatmentExperimentalDevice: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC
Receives: Device: Flow diversion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Efficacy and Performance Endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis and no retreatment of the target aneurysm from the index procedure to the 12-month follow-up visit.

    The Primary Efficacy and Performance Endpoint is a composite of 100% target aneurysm occlusion (Raymond-Roy Class I) without significant stenosis (defined as ≤50% stenosis) of the parent artery based on independent core lab evaluation of the 12-month follow-up angiogram (DSA), and no subsequent treatment at the target aneurysm at the 12-month follow-up visit.

    Measured: 12 months

  2. The Primary Safety Endpoint: Number of subjects with ischemic or hemorrhagic stroke or neurologic death from treatment to 12-months, as adjudicated by a Clinical Events Committee.

    The Primary Safety Endpoint is the incidence of major stroke (ischemic or hemorrhagic) in the territory supplied by the treated artery, defined as an increase in NIHSS score by 4 points, or neurologic death within 1 year after treatment.

    Measured: From treatment - 12 months

Secondary outcomes (3)

  1. Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2

    Morbi-mortality refers to the combined study of morbidity (the state of being diseased or unhealthy) and mortality (the state of being subject to death) that results in a modified Rankin Scale (mRS) score > 2

    Measured: 30 days post procedure and at the following timepoints: 6-month, 1 year, 3 years, and 5 years

  2. Secondary Safety Endpoint #2: Number of subjects with procedural and/or device-related serious adverse events (SAE)

    The number of subjects that have a reported event related to the procedure, the device (based on FDAs definition of a serious adverse event), or both will be analyzed by an independent Clinical Events Committee

    Measured: 30 days post procedure and at the following timepoints: 6-months, 1 year, 3 years, and 5 years

  3. Secondary Safety Endpoint #3: Number of subjects with a neurologic event of interest defined as any death, neurological death, target aneurysm rupture or re-rupture, target aneurysm retreatment, or intracranial hemorrhage

    The number of subjects who have died by any cause, who have had their treated target aneurysm rupture or re-rupture, who have had their target aneurysm retreated, or who have had an intracranial hemorrhage, as adjudicated by an independent Clinical Events Committee

    Measured: 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start16 Mar 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, multicenter, single-arm
Masking
None (open label)
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143019
Sponsor's protocol ID
pCT-002-23
Acronym
PIANO
Status last verified
Apr 2026
First submitted
12 Aug 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Flow diversion in people with Hemorrhagic Stroke and Aneurysm, Intracranial, run by phenox Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mairéad Cleary (+353 91 740 100, mairead.cleary@wallabyphenox.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy and Performance Endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis and no retreatment of the target aneurysm from the index procedure to the 12-month follow-up visit. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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