PHIL in the Treatment of Intracranial dAVF. (PHIL dAVF)

MicroVention

Status

Completed

Conditions

Arteriovenous Dural Fistula

Treatments

Device: PHIL® Liquid Embolic System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03467542

CL11005

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

22 to 80 years old

Volunteers

No Healthy Volunteers

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.