Clinical trial NCT03731000: PHIL® Embolic System Pediatric IDE
Official title: Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterio-venous Fistula
Intracranial Arteriovenous Malformations
Keywords: Pediatric
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 15
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with neurological death or major ipsilateral stroke
timeFrame: 12 months
measure: Proportion of participants with angiographic occlusion
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of angiographic cure
timeFrame: up to 12 months
measure: Incidence of new-onset permanent morbidity
timeFrame: up to 12 months
measure: Incidence of new-onset Intracranial hemorrhage (ICH)
timeFrame: up to 12 months
measure: Number of significant technical events
timeFrame: up to 12 months
measure: Incidence of device-related adverse events at procedure
timeFrame: Day 1 during procedure
measure: Incidence of device-related adverse events at 30 days
timeFrame: at 30 days
measure: Incidence of device-related mortality
timeFrame: at 30 days
measure: Incidence of procedure related adverse events
timeFrame: up to 12 months
measure: Incidence of cranial neuropathy
timeFrame: up to 12 months
measure: Pediatric NIH Stroke Scale (PedNIHSS)
timeFrame: at 12 months
measure: The Pediatric Stroke Outcome Measure (PSOM)
timeFrame: at 12 months
measure: Number of procedures
timeFrame: up to 6 months
measure: Procedure time
timeFrame: average of 3-4 hours
measure: Dosage of Radiation exposure
timeFrame: average of 60 minutes
measure: Radiation exposure time
timeFrame: average of 60 minutes
measure: Injected volume of PHIL
timeFrame: at time of procedure, average of 3-4 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Alejandro Berenstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Johanna Fifi, MD
role: PRINCIPAL_INVESTIGATOR
References: