PHIL in the Treatment of Intracranial dAVF. (PHIL dAVF)

December 9, 2024 updated by: Microvention-Terumo, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dAVF treatment
PHIL® Liquid Embolic System
Device: PHIL® Liquid Embolic System
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects With Neurological Death or Ipsilateral Stroke
Time Frame: 30 days
Reported incidences of death or ipsilateral stroke
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Events During the PHIL Embolization Procedure(s)
Time Frame: During the procedure
Reported incidences of technical events with PHIL device
During the procedure
Device-related Adverse Events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: J Mocco, MD, Mt. Sinai
  • Principal Investigator: Alan Boulos, MD, Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

December 12, 2022

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL11005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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