PHIL® Embolic System Pediatric IDE

NCT03731000 | Recruiting DMC FDA Device

• 1 other identifier: GCO 18-1298
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Intracranial Arteriovenous Malformations; Arterio-venous Fistula

Keywords

Pediatric

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with neurological death or major ipsilateral stroke

  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

  12 months

• Proportion of participants with angiographic occlusion

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

  up to 12 months

Secondary Outcomes (16)

• Incidence of angiographic cure

  up to 12 months

• Incidence of new-onset permanent morbidity

  up to 12 months

• Incidence of new-onset Intracranial hemorrhage (ICH)

  up to 12 months

• Number of significant technical events

  up to 12 months

• Incidence of device-related adverse events at procedure

  Day 1 during procedure

Study Arms (1)

PHIL® device

EXPERIMENTAL

Using device

Device: PHIL® device

Interventions

PHIL® device DEVICE

Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

PHIL® device

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alejandro Berenstein: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula; Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Intracranial Arterial Diseases

Study Officials

• Alejandro Berenstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Tomoyoshi Shigematsu, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukaina Davdani

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single Group

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: November 5, 2018
• Study Start: April 16, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)