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

June 5, 2026 updated by: phenox Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Principal Investigator:
          • Andrew Ducruet, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz
        • Contact:
        • Principal Investigator:
          • Joshua Seinfeld, MD
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Swedish Medical Research Center
        • Principal Investigator:
          • Don Frei, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Research Institute
        • Principal Investigator:
          • Eric Sauvageau, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Atlanta Hospital
        • Contact:
        • Principal Investigator:
          • Michael F Stiefel, MD, PhD
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krishna Joshi, MD
    • Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Adel Malek, MD
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • UBNS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adnan Siddiqui, MD, PhD, FAHA
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital - Northwell Health
        • Principal Investigator:
          • Athos Patsalides, MD
        • Contact:
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University Health Medical Center
        • Contact:
        • Principal Investigator:
          • Richard T Dalyai, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma
        • Principal Investigator:
          • Hakeem Shakir, MD
        • Contact:
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University Hospital (OHSU) / Oregon Stroke Center
        • Contact:
        • Principal Investigator:
          • Ryan A Priest, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Rohan Chitale, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington - Harborview Medical Center
        • Principal Investigator:
          • Michael Levitt, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years
  2. Subject has a mRS ≤2 before the index procedure

  3. 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:

    1. Saccular or fusiform morphology
    2. Located in the internal carotid artery and its branches
    3. Aneurysm neck ≥4 mm or dome-to-neck ratio <2
    4. Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
  4. Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.

Exclusion Criteria:

  1. Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
  2. Any other known IA requiring treatment within 3 months post-procedure
  3. Subarachnoid hemorrhage in the past 30 days prior to the index procedure
  4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
  5. 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
  6. Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
  7. Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
  8. Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
  9. Known serious sensitivity to radiographic contrast agents that cannot be managed medically
  10. Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
  11. Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
  12. Known renal failure with a serum creatinine >2.5 mg/dl (or 220 μmol/l) not on dialysis
  13. Contraindication to CT scan, MRI, or angiography
  14. Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
  15. Known coagulopathy, or an admission International Normalized Ratio >3.0 without oral anticoagulation therapy, or an admission platelet count of <100000
  16. Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
  17. Unable to complete the required study follow-ups
  18. Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
  19. Participating in another clinical trial that could affect participation or primary outcomes of this study
  20. Women currently pregnant or wish to become pregnant during the study or breast feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention/Treatment
Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC
Device: Flow 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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.
Time Frame: From treatment - 12 months
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.
From treatment - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2
Time Frame: 30 days post procedure and at the following timepoints: 6-month, 1 year, 3 years, and 5 years
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
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)
Time Frame: 30 days post procedure and at the following timepoints: 6-months, 1 year, 3 years, and 5 years
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
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
Time Frame: 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure
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
30 days post procedure and at the following timepoints: 6-months and 12-months post procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Analysis #1: Number of subjects with 100% occlusion (Raymond-Roy Class I) of the target aneurysm at follow-up visits
Time Frame: Post procedure: 6-months, 1 year, 3 years and at 5 years
The number of subjects with 100% occlusion (Raymond-Roy Class I) of the target aneurysm at follow-up visits will be analyzed
Post procedure: 6-months, 1 year, 3 years and at 5 years
Additional Analysis #2: Number of subjects with retreatment of the target aneurysm
Time Frame: Post Procedure: 6-months, 1 year, 3 years, and at 5 years
The number of subjects with target aneurysm retreatment will be analyzed
Post Procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #3: Number of subjects with a target aneurysm recanalization/recurrence
Time Frame: Post procedure: 6-months, 1 year, 3 years, and at 5 years
The number of subjects with target aneurysm recanalization or recurrence will be analyzed
Post procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #4: Number of subjects with significant (> 50% stenosis) parent artery stenosis, as assessed independent core laboratory post-procedure
Time Frame: Post procedure: 6-months, 1 year, 3 years, and at 5 years
The number of subjects with significant (> 50% stenosis) parent artery stenosis, as assessed post-procedure by independent core lab will be analyzed
Post procedure: 6-months, 1 year, 3 years, and at 5 years
Additional Analysis #5: Number of subjects with technical device success defined as complete coverage of the target aneurysm with ≥1 FMD) per subject at the target site during the index procedure
Time Frame: Immediately after the Index Procedure
The number of subjects with complete coverage of the target aneurysm with ≥1 FMD per subject at the target site during the index procedure, as assessed by the independent core lab
Immediately after the Index Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

phenox Inc.

Collaborators

Phenox GmbH

Investigators

  • Principal Investigator: Demetrius Lopes, MD, Advocate Aurora Research Institute, LLC
  • Principal Investigator: Jared Knopman, MD, The Joan and Sanford I. Weill Medical College of Cornell University
  • Principal Investigator: Eytan Raz, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Actual)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pCT-002-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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