NCT03317821

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dural Arteriovenous Fistula

Timeline

• Start date: 2017-09-18
• Primary completion: 2020-03-11
• Completion: 2020-03-11
• First posted: 2017-10-23
• Last updated: 2021-07-29

Locations

16 sites across 5 countries: Denmark, France, Spain, Sweden, United Kingdom