PHIL in the Treatment of Intracranial dAVF.

Not Recruiting

Trial ID: NCT03467542

Purpose

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.

Official Title

PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas

Stanford Investigator(s)

Jeremy J. Heit, MD, PhD
Jeremy J. Heit, MD, PhD

Associate Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery

Huy M. Do, MD
Huy M. Do, MD

Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery and of Otolaryngology - Head & Neck Surgery (OHNS)

Eligibility

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.

Intervention(s):

device: PHIL® Liquid Embolic System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305