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.
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
- Conditions the study is for
- Hemorrhagic Stroke, Aneurysm, Intracranial, Saccular Aneurysm
- 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
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
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- 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.
Nguyet T Labenski contact
25 sites in 1 country
United States25 sites, 25 recruiting
- 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
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.
- Conditions
- Hemorrhagic Stroke, Aneurysm, Intracranial, Saccular Aneurysm, Fusiform Aneurysm, Brain Aneurysm
- 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 group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | Device: 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.
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
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)
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
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
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.
- First posted27 Aug 2025
- Study start16 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- phenox Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phenox GmbH
- Responsible party
- Sponsor
- Investigators
- Demetrius Lopes, MD, Principal investigator, Advocate Aurora Research Institute, LLCJared Knopman, MD, Principal investigator, The Joan and Sanford I. Weill Medical College of Cornell UniversityEytan Raz, MD, Principal investigator, NYU Langone Health
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