PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Dural Arteriovenous Fistula Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dural Arteriovenous Fistula
• Fistula

• NCT number: NCT03317821
• Study type: Observational [Patient Registry]
• Source: Microvention-Terumo, Inc.
• Status: Completed
• Start date: September 18, 2017
• Completion date: March 11, 2020