Back to resultsPHIL in the Treatment of Intracranial dAVF. (PHIL dAVF)
Primary Purpose
Arteriovenous Dural Fistula
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PHIL® Liquid Embolic System
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Dural Fistula focused on measuring Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
Eligibility Criteria
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.
Sites / Locations
- Albany Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dAVF treatment
Arm Description
PHIL® Liquid Embolic System
Outcomes
Primary Outcome Measures
Subjects with neurological death or ipsilateral stroke
Reported incidences of death or ipsilateral stroke
Secondary Outcome Measures
Technical events during the PHIL embolization procedure(s)
Reported incidences of technical events with PHIL device
Device-related adverse events
Full Information
NCT ID
NCT03467542
First Posted
March 6, 2018
Last Updated
February 8, 2022
Sponsor
Microvention-Terumo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03467542
Brief Title
PHIL in the Treatment of Intracranial dAVF.
Acronym
PHIL dAVF
Official Title
PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Dural Fistula
Keywords
Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dAVF treatment
Arm Type
Experimental
Arm Description
PHIL® Liquid Embolic System
Intervention Type
Device
Intervention Name(s)
PHIL® Liquid Embolic System
Intervention Description
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
Primary Outcome Measure Information:
Title
Subjects with neurological death or ipsilateral stroke
Description
Reported incidences of death or ipsilateral stroke
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical events during the PHIL embolization procedure(s)
Description
Reported incidences of technical events with PHIL device
Time Frame
During the procedure
Title
Device-related adverse events
Time Frame
3-6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Mocco, MD
Organizational Affiliation
Mt. Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Boulos, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PHIL in the Treatment of Intracranial dAVF.
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