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PHIL in the Treatment of Intracranial dAVF.
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
Associate Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery
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
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305