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

NCT07143019 | Recruiting DMC FDA Device

• 1 other identifier: pCT-002-23
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Hemorrhagic Stroke; Aneurysm, Intracranial; Saccular Aneurysm; Fusiform Aneurysm; Brain Aneurysm

Keywords

Neurovascular Intervention; phenox; Brain; Unruptured Aneurysm; Flow diversion; Flow diverter; Occlusion; Flow modulation device

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From treatment - 12 months

Secondary Outcomes (3)

• Secondary Safety Endpoint #1: Number of subjects with 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)

  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

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

Other Outcomes (5)

• Additional Analysis #1: Number of subjects with 100% occlusion (Raymond-Roy Class I) of the target aneurysm at follow-up visits

  Post procedure: 6-months, 1 year, 3 years and at 5 years

• Additional Analysis #2: Number of subjects with retreatment of the target aneurysm

  Post Procedure: 6-months, 1 year, 3 years, and at 5 years

• Additional Analysis #3: Number of subjects with a target aneurysm recanalization/recurrence

  Post procedure: 6-months, 1 year, 3 years, and at 5 years

Study Arms (1)

Intervention/Treatment

EXPERIMENTAL

Device: Flow diversion using the p48 MW HPC Device: Flow diversion using the p64 MW HPC

Device: Flow diversion

Interventions

Flow diversion DEVICE

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.

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• phenox Inc.: lead
• Phenox GmbH: collaborator

Study Sites (11)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

Swedish Medical Research Center

Englewood, Colorado, 80113, United States

RECRUITING

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

UBNS

Buffalo, New York, 14203, United States

RECRUITING

North Shore University Hospital - Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

The University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Stroke; Intracranial Aneurysm; Aneurysm; Bites and Stings

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mairéad Cleary

CONTACT

+353 91 740 100; mairead.cleary@wallabyphenox.com

Nguyet T Labenski

CONTACT

nguyet.labenski@wallabyphenox.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single-arm

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 27, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2032
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)