PHIL® Embolic System Pediatric IDE

Alejandro Berenstein15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arterio-venous Fistula Intracranial Arteriovenous Malformations

Interventions

PHIL® deviceDEVICE

Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Hospital

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: up to 12 months

Secondary Outcomes

Incidence of angiographic cure

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

Time frame: up to 12 months

Incidence of new-onset permanent morbidity

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

Time frame: up to 12 months

Incidence of new-onset Intracranial hemorrhage (ICH)

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

Time frame: 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.

Time frame: up to 12 months

Incidence of device-related adverse events at procedure

Central Contacts

Sukaina Davdani

CONTACT

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

Cynthia Nguyen

CONTACT

(212) 241-2524 cynthia.nguyen@mountsinai.org

Data from ClinicalTrials.gov

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