PHIL in the Treatment of Intracranial dAVF.

Not Applicable

Completed

• Conditions: Arteriovenous Dural Fistula
• Interventions: Device: PHIL® Liquid Embolic System

• Registration Number: NCT03467542
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Study Start: 2018-08-24
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2024-05
• Results First Submitted: 2024-12-09
• Results First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Results First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age 22 - 80 years.
• Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
• Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
• Subject has an intracranial dAVF

Exclusion Criteria

• Subject having multiple dAVFs to be treated.
• Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
• Subject has known allergies to dimethylsulfoxide, iodine.
• Subject is currently participating in another clinical study
• Female subject is currently pregnant.
• Subject has co-morbid conditions that may limit survival to less than 24 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dAVF treatment	PHIL® Liquid Embolic System	PHIL® Liquid Embolic System

Primary Outcome Measures

Name	Time	Method
Subjects With Neurological Death or Ipsilateral Stroke	30 days	Reported incidences of death or ipsilateral stroke

Secondary Outcome Measures

Name	Time	Method
Technical Events During the PHIL Embolization Procedure(s)	During the procedure	Reported incidences of technical events with PHIL device
Device-related Adverse Events	30 days

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States