Recruiting

PHIL® Embolic SystemPHIL® Embolic System Pediatric IDE

Sponsor:

Alejandro Berenstein

Code:

NCT03731000

Conditions

Arterio-venous Fistula

Intracranial Arteriovenous Malformations

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

PHIL® device

Study Details

Brief summary:

The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs.

The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.

Conditions

Arterio-venous Fistula

Intracranial Arteriovenous Malformations

Study ID

NCT03731000

Start date

Apr 16, 2019

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PHIL® device

Using device

Interventions

PHIL® device

Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Primary outcome measure

Proportion of participants with neurological death or major ipsilateral stroke [ Time Frame: 12 months ]
Proportion of participants with angiographic occlusion [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Sukaina Davdani

(212) 241-2524 sukaina.davdani@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Tomoyoshi Shigematsu

More Information

Sponsor

Alejandro Berenstein

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alejandro Berenstein on 2026-03-27.