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OpenTrials
Completed

NCT Number: NCT03467542

PHIL in the Treatment of Intracranial dAVF.

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.

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Key information

Conditions

Arteriovenous Dural Fistula Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Vascular Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Nervous System Diseases Nervous System Malformations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Malformations

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PHIL® Liquid Embolic System

Device

The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)

Primary outcomes

  1. Subjects With Neurological Death or Ipsilateral Stroke

    Time frame: 30 days

    Reported incidences of death or ipsilateral stroke

Secondary outcomes

  1. Technical Events During the PHIL Embolization Procedure(s)

    Time frame: During the procedure

    Reported incidences of technical events with PHIL device

  2. Device-related Adverse Events

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

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

Acronym: PHIL dAVF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2018
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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