PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Microvention-Terumo, Inc.70 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dural Arteriovenous Fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form 2. 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). 3. Patient is at least 18 years of age. Exclusion Criteria: 1. Patient has multiple dAVFs to be treated. 2. 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. 3. Patient does not give consent to the collection and processing of data required for centralized monitoring 3\. Any condition that could prevent patient follow up.

Locations (16)

Rigshospitalet University

Copenhagen, Denmark

CHU Pellgrin

Bordeaux, France

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Outcomes

Primary Outcomes

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

Neurological assessment by mRS

Time frame: 1 month

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

Cure rate assessment by Angiography

Time frame: 3-6 months after last embolization

Secondary Outcomes

Number of adverse events and assessment of neurological status

Neurological assessment by mRS

Time frame: 3-6 months after last embolization

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

Assessed by Quality of Life Questionnaire EQ 5D

Time frame: 3-6 months after last embolization

Data from ClinicalTrials.gov

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