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PHIL in the Treatment of Intracranial dAVF.

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
22 Years
Maximum Age
80 Years

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.

Join this Trial

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Study Stats
Protocol No.
18-000890
Category
Radiological Sciences
Contact
Victoria Rueda
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03467542
For detailed technical eligibility, visit ClinicalTrials.gov.