PHIL™ Liquid Embolic System

PHIL dAVF: Evaluation in the Endovascular Treatment of Intracranial Dural AVF

"The PHIL-dAVF study provides evidence about the efficacy and safety of PHIL in the treatment of intracranial dAVFs, with outcomes comparable to existing liquid embolic agents reported in the literature."

Patients

Countries

France, Spain, UK, Sweden, Denmark

Clinical Centers

Design

Single arm prospective

Scope

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL used with or without other embolization products.

Purpose

Assess safety and efficacy of PHIL used with or without other embolization products (cyanoacrylate glue, coils, balloon, etc.) in endovascular embolization of dAVF.

Endpoints

Efficacy: Cure rate and clinical course of the patient stability/improvement/deterioration at 3-6 months after last embolization compared to baseline

Cure rate assessed by Angiography validated by Corelab

Safety: Number of adverse events and assessment of neurological status (mRS) at 1 month after each embolization compared to baseline