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

phenox Inc. · with Phenox GmbH · NCT07143019

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
214
US sites recruiting
25
Study start
March 16, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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.

Being studied: Flow diversion

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Barrow Neurological Institute

    Phoenix, AZ 85013

    Site contact: Alex Reynolds · 602-406-6227 · alex.reynolds@commonspirit.org

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

    Los Angeles, CA 90033

    Site contact: Kelly Hu · 323-442-0661 · Kelly.Hu@med.usc.edu

  • UCSF Medical Center

    San Francisco, CA 94143

    Site contact: Atakan Orscelik, MD · 415-353-7500 · atakan.orscelik@ucsf.edu

  • University of Colorado Anschutz

    Aurora, CO 80045

    Site contact: Jennifer Maitlen, RN, BSN · 303-724-1995 · jennifer.maitlen@cuanschutz.edu

  • Swedish Medical Research Center

    Englewood, CO 80113

    Site contact: Ashley Thompson · 303-907-5634 · Ashley.Thompson3@HCAhealthcare.com

  • Baptist Health Research Institute

    Jacksonville, FL 32207

    Site contact: Dollie Jennings, Ph.D · 904-202-7063 · Sarah.Jennings@bmcjax.com

  • Piedmont Atlanta Hospital

    Atlanta, GA 30309

    Site contact: Shardae Shavers · 404-605-2277 · Shardae.Shavers@piedmont.org

  • Northwestern Medicine

    Chicago, IL 60611

    Site contact: Pouya Nazari · 312-695-9014 · pouya.nazari@nm.org

  • Advocate Lutheran General Hospital

    Park Ridge, IL 60068

    Site contact: Victor Arroyo, Arroyo · 847-723-7950 · victor.arroyo@aah.org

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Julia Ivey · julia-ivey@uiowa.edu

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Ashley Paro · 617-636-5000 · Ashley.Paro@tuftsmedicine.org

  • WashU Medicine

    St Louis, MO 63110

    Site contact: Ramie Heo · 314-747-4569 · heor@wustl.edu

  • UBNS

    Buffalo, NY 14203

    Site contact: Michaela Laskowski · mlaskowski@ubns.com

  • North Shore University Hospital - Northwell Health

    Manhasset, NY 11030

    Site contact: Betsy Moclair, RN, MBA,CCRC · 917-673-4908 · bmoclair@northwell.edu

  • NYU Langone Health

    New York, NY 10016

    Site contact: Maria Fabal · 212-263-1004 · Maria.Fabal@nyulangone.org

  • NewYork-Presbyterian / Weill Cornell Medical Center

    New York, NY 10065

    Site contact: Jackson Hagen · 913-953-6961 · jrh4002@med.cornell.edu

  • Stony Brook University Hospital

    Stony Brook, NY 11794

    Site contact: Marlene Baumeister, RN, BSN, CCRC, CNRN · 631-444-1610 · Marlene.Baumeister@stonybrookmedicine.edu

  • East Carolina University Health Medical Center

    Greenville, NC 27834

    Site contact: Miriam Wood, MPH · 252-744-5696 · miriam.wood@ecuhealth.org

  • The University of Oklahoma

    Oklahoma City, OK 73104

    Site contact: Sanaa Hameed · 405-271-8001 · Sanaa-Hameed@ouhsc.edu

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

    Portland, OR 97239

    Site contact: Emma Blackburn · blackbue@ohsu.edu

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Sophia Bautista · 215-906-4165 · sophia.bautista@pennmedicine.upenn.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Morgan Mohler · 615-421-1507 · morgan.mohler@vumc.org

  • UT Southwestern Medical Center

    Dallas, TX 75235

    Site contact: Tyfe Oderinde, MS · 214-648-9905 · Bolutyfe.Oderinde@UTSouthwestern.edu

  • University of Utah Health

    Salt Lake City, UT 84132

    Site contact: Heather A Meyer · 801-587-2924 · heather.a.meyer@hsc.utah.edu

  • University of Washington - Harborview Medical Center

    Seattle, WA 98104

    Site contact: Tyler Ip · 206-744-9389 · siutai@uw.edu

Study contacts (from the official record)

  • Mairéad Cleary · +353 91 740 100 · mairead.cleary@wallabyphenox.com
  • Nguyet T Labenski · nguyet.labenski@wallabyphenox.com
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The Use of p48/64 MW HPC Flow Modulation Device in the Treatment… (NCT07143019) | Bored Studies