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NCT Number: NCT03731000

PHIL® Embolic System Pediatric IDE

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.

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Key information

Conditions

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

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Tomoyoshi Shigematsu

PRINCIPAL_INVESTIGATOR

About this study

Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.

Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHIL® device

Device

Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Primary outcomes

  1. Proportion of participants with neurological death or major ipsilateral stroke

    Time frame: 12 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

  2. Proportion of participants with angiographic occlusion

    Time frame: up to 12 months

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

Secondary outcomes

  1. Incidence of angiographic cure

    Time frame: up to 12 months

    Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.

  2. Incidence of new-onset permanent morbidity

    Time frame: up to 12 months

    New-onset permanent morbidity up to 12 month follow-up

  3. Incidence of new-onset Intracranial hemorrhage (ICH)

    Time frame: up to 12 months

    New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up

  4. Number of significant technical events

    Time frame: up to 12 months

    Clinically significant technical events during the PHIL embolization procedure(s) including but not limited to reflux of embolic material, migration of the embolic material, catheter entrapment or damage, and vessel dissection.

  5. Incidence of device-related adverse events at procedure

    Time frame: Day 1 during procedure

    Incidence of device-related adverse events at procedure at Day 1

  6. Incidence of device-related adverse events at 30 days

    Time frame: at 30 days

    Incidence of device-related adverse events at 30 days.

  7. Incidence of device-related mortality

    Time frame: at 30 days

    Device-related mortality at 30 days

  8. Incidence of procedure related adverse events

    Time frame: up to 12 months

    Procedure related adverse events including complications of arterial puncture, contrast-induced nephropathy, renal and anesthesia-related complications.

  9. Incidence of cranial neuropathy

    Time frame: up to 12 months

    Incidence of cranial neuropathy up to 12 months follow-up

  10. Pediatric NIH Stroke Scale (PedNIHSS)

    Time frame: at 12 months

    PedNIHSS - 11 item instrument measuring levels of impairment on a scale of 0-42 with higher score demonstrating higher levels of impairment

  11. The Pediatric Stroke Outcome Measure (PSOM)

    Time frame: at 12 months

    PSOM - measures stroke outcomes across 115 test items. On completion of the PSOM examination, the neurologist scores a Summary of Impressions containing 5 subscales: right sensorimotor, left sensorimotor (each with subcategories), language production, language comprehension, and cognitive/behavioral. Subscale scoring is 0 (no deficit), 0.5 (mild deficit, normal function), 1 (moderate deficit, decreased function), or 2 (severe deficit, missing function). The PSOM total score is the sum of the 5 subscale scores and ranges from 0 (no deficit) to 10 (maximum deficit).

  12. Number of procedures

    Time frame: up to 6 months

    Number of procedures required to treat the fistula at 3-6 month follow-up

  13. Procedure time

    Time frame: average of 3-4 hours

    Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions)

  14. Dosage of Radiation exposure

    Time frame: average of 60 minutes

  15. Radiation exposure time

    Time frame: average of 60 minutes

  16. Injected volume of PHIL

    Time frame: at time of procedure, average of 3-4 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Sukaina Davdani

CONTACT

[email protected]

(212) 241-2524

Sponsors and collaborators

Lead sponsor

Alejandro Berenstein

Other

Registry information

Official study title

Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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