PHIL in the Treatment of Intracranial dAVF.

NCT03467542 | Completed Results DMC FDA Device

• 1 other identifier: CL11005
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Dural Fistula

Keywords

Fistula; Intracranial; Dural; Arteriovenous; Liquid Embolic

Outcome Measures

Primary Outcomes (1)

• Subjects With Neurological Death or Ipsilateral Stroke

  Reported incidences of death or ipsilateral stroke

  30 days

Secondary Outcomes (2)

• Technical Events During the PHIL Embolization Procedure(s)

  During the procedure

• Device-related Adverse Events

  30 days

Study Arms (1)

dAVF treatment

EXPERIMENTAL

PHIL® Liquid Embolic System

Device: PHIL® Liquid Embolic System

Interventions

PHIL® Liquid Embolic System DEVICE

The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)

dAVF treatment

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Central Nervous System Vascular Malformations; Fistula

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Gash
• Organization: Terumo Neuro

robert.gash@microvention.com

714-247-8000

Study Officials

• J Mocco, MD

  Mt. Sinai

  PRINCIPAL INVESTIGATOR

• Alan Boulos, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 16, 2018
• Study Start: August 24, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-05

Locations

US (1)