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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)
Huy M. Do, MD
Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery and of Otolaryngology - Head & Neck Surgery (OHNS)
Jeremy J. Heit, MD, PhD
Associate Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery
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