PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    70
  • sponsor
    Microvention-Terumo, Inc.
Updated on 8 December 2019
Investigator
Habib NACER-CHERIF
Primary Contact
CHU Limoges (1.2 mi away) Contact
+14 other location

Summary

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

Description

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.

Details
Clinical Study IdentifierNCT03317821
SponsorMicrovention-Terumo, Inc.
Last Modified on8 December 2019

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Persistent cerebral embryonic artery?
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
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