PHIL in the Treatment of Intracranial dAVF.



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:22 - 80
Updated:9/12/2018
Start Date:August 24, 2018
End Date:December 2020
Contact:Jennifer Jelf
Email:jennifer.jelf@microvention.com
Phone:714.247.8187

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
1
site
Albany Medical Center
Albany, New York 12208
Principal Investigator: John Dalfino, MD
?
mi
from
Albany, NY
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