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Completed

NCT Number: NCT03317821

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet University, Copenhagen, Denmark

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About this study

This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.

The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.

The expected approximate study duration is 38 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
  • Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
  • Patient is at least 18 years of age.

Exclusion criteria

  • Patient has multiple dAVFs to be treated.
  • Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
  • Patient does not give consent to the collection and processing of data required for centralized monitoring
  • Any condition that could prevent patient follow up.

Treatment and study plan

Primary outcomes

  1. Number of adverse events and assessment of neurological status at 1 month after each embolization

    Time frame: 1 month

    Neurological assessment by mRS

  2. Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)

    Time frame: 3-6 months after last embolization

    Cure rate assessment by Angiography

Secondary outcomes

  1. Number of adverse events and assessment of neurological status

    Time frame: 3-6 months after last embolization

    Neurological assessment by mRS

  2. Improvement in the quality of life of the patient and changes in patients symptoms

    Time frame: 3-6 months after last embolization

    Assessed by Quality of Life Questionnaire EQ 5D

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Collaborators

  • ClinSearch

Registry information

Official study title

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Jul 29, 2021

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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