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PHIL® Embolic System for Intracranial dAVFs in Children

This study is looking at how well the PHIL® Embolic System works to treat intracranial dural arteriovenous fistulas (dAVFs) in children. A dAVF is an abnormal connection between arteries and veins in the brain. The PHIL® Embolic System is a special device used to block these abnormal connections. Researchers want to see if it's safe and helpful. They will be looking at whether participants have a stroke or neurological death within 12 months, and if the dAVF is closed off. This study is for people under 22 years old who have an intracranial dAVF. The study aims to enroll 15 participants, but its current recruitment status is unclear.

Study design
This is a single-center study, meaning it's happening at one location, and everyone receives the PHIL® device. It aims to include 15 participants.
What's involved
You and your legal guardian must be willing and able to follow all study requirements, including a specified follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months to check for neurological events and whether the dAVF is closed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03731000

PHIL® Embolic System Pediatric IDE

Recruiting
NAUp to 21InterventionalTreatment
Alejandro Berenstein
~15 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:PHIL® device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with neurological death or major ipsilateral stroke
Measured over 12 months
+1 more outcome measured

Conditions

Arterio-venous Fistula
Intracranial Arteriovenous Malformations

Explore related trials

Arteriovenous FistulaIntracranial Arteriovenous Malformation

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Alejandro Berenstein, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Tomoyoshi Shigematsu, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Sukaina Davdani
[email protected]
(212) 241-2524
Email the study team

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Eligibility criteria

Inclusion

Subject is \<22 years of age
Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.

Exclusion

Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
Female subject is currently pregnant.
Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
Evidence of active infection at the time of treatment.
Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
Subject weighs ≤ 2.5kg Angiographic
Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
Contra-indication to DSA, CT scan or MRI/ MRA
History of intracranial vasospasm not responsive to medical therapy
Extra-cranial stenosis or parent vessel stenosis \> 50% proximal to the target lesion to be treated.
Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis

What this trial measures

  • Proportion of participants with neurological death or major ipsilateral stroke12 months

    The proportion of subjects with neurological death or major ipsilateral stroke (defined as a major stroke within the vascular distribution of the vessel targeted for treatment) within 12 months following completion of treatment, reported as one composite data variable

  • Proportion of participants with angiographic occlusionup to 12 months

    Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment