PHIL in the Treatment of Intracranial dAVF.

Arteriovenous Dural Fistula Clinical Trial

— PHIL dAVF  

Official title:

PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467542
• Other study ID #: CL11005
• Status: Completed
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: December 12, 2022

Study information

• Verified date: May 2024
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Dural Fistula
• Fistula

Intervention

Device:
• PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects with neurological death or ipsilateral stroke	Reported incidences of death or ipsilateral stroke	30 days
Secondary	Technical events during the PHIL embolization procedure(s)	Reported incidences of technical events with PHIL device	During the procedure
Secondary	Device-related adverse events		3-6 month follow-up