PHIL® Embolic System Pediatric IDE

Alejandro Berenstein

Status

Enrolling

Conditions

Arterio-venous Fistula

Intracranial Arteriovenous Malformations

Treatments

Device: PHIL® device

Study type

Interventional

Funder types

Other

Identifiers

NCT03731000

GCO 18-1298

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

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