PHIL in the Treatment of Intracranial dAVF.

Microvention-Terumo, Inc.64 enrolled

Overview

This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arteriovenous Dural Fistula

Interventions

PHIL® Liquid Embolic SystemDEVICE

The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)

Eligibility

Sex: ALLMin age: 22 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 22 - 80 years. * Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period. * Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures. * Subject has an intracranial dAVF Exclusion Criteria: * Subject having multiple dAVFs to be treated. * Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated). * Subject has known allergies to dimethylsulfoxide, iodine. * Subject is currently participating in another clinical study * Female subject is currently pregnant. * Subject has co-morbid conditions that may limit survival to less than 24 months.

Locations (1)

Albany Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

Subjects With Neurological Death or Ipsilateral Stroke

Reported incidences of death or ipsilateral stroke

Time frame: 30 days

Secondary Outcomes

Technical Events During the PHIL Embolization Procedure(s)

Reported incidences of technical events with PHIL device

Time frame: During the procedure

Device-related Adverse Events

Time frame: 30 days

Data from ClinicalTrials.gov

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