PHIL® Embolic System Pediatric IDE

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arterio-venous Fistula, Intracranial Arteriovenous Malformations

Intervention / Treatment
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* Device: PHIL® device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHIL® device<br>Using device | Device: PHIL® device<br>* Using PHIL® device for treatment of intracranial dural arteriovenous fistulas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of angiographic cure | Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment. | up to 12 months | 
| Incidence of new-onset permanent morbidity | New-onset permanent morbidity up to 12 month follow-up | up to 12 months | 
| Incidence of new-onset Intracranial hemorrhage (ICH) | New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up | up to 12 months | 
| Number of significant technical events | 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. | up to 12 months | 
| Incidence of device-related adverse events at procedure | Incidence of device-related adverse events at procedure at Day 1 | Day 1 during procedure | 
| Incidence of device-related adverse events at 30 days | Incidence of device-related adverse events at 30 days. | at 30 days | 
| Incidence of device-related mortality | Device-related mortality at 30 days | at 30 days | 
| Incidence of procedure related adverse events | Procedure related adverse events including complications of arterial puncture, contrast-induced nephropathy, renal and anesthesia-related complications. | up to 12 months | 
| Incidence of cranial neuropathy | Incidence of cranial neuropathy up to 12 months follow-up | up to 12 months | 
| Pediatric NIH Stroke Scale (PedNIHSS) | PedNIHSS - 11 item instrument measuring levels of impairment on a scale of 0-42 with higher score demonstrating higher levels of impairment | at 12 months | 
| The Pediatric Stroke Outcome Measure (PSOM) | 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). | at 12 months | 
| Number of procedures | Number of procedures required to treat the fistula at 3-6 month follow-up | up to 6 months | 
| Procedure time | Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions) | average of 3-4 hours | 
| Dosage of Radiation exposure |  | average of 60 minutes | 
| Radiation exposure time |  | average of 60 minutes | 
| Injected volume of PHIL |  | at time of procedure, average of 3-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric