PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.

The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.

Study Overview

• Status: Completed
• Conditions: Dural Arteriovenous Fistula

Detailed Description

This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.

The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.

The expected approximate study duration is 38 months.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet University
• France
  • Bordeaux, France, 33000
    • CHU Pellgrin
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Bicêtre
  • Limoges, France, 87000
    • CHU Limoges
  • Paris, France, 75010
    • La Fondation Rothschild
  • Toulouse, France, 31059
    • Hopital Pierre Paul Riquet
• Spain
  • Barcelona, Spain, 08190
    • Hospital Universitario General de Catalunya
  • Madrid, Spain, 28006
    • Hospital Nuestra Señora del Rosario
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Málaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
• Sweden
  • Umeå, Sweden, 90746
    • Universitetssjukhus Umea
  • Uppsala, Sweden, 75185
    • Uppsala University
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospital Birmingham
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patients having an untreated dural arteriovenous fistula requiring treatment will be screened by the investigational sites. Those eligible to be treated with PHIL® will be enrolled after having dated and signed an informed consent form as per appropriate regulation in the participating country.

Description

Inclusion Criteria:

1. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
2. Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
3. Patient is at least 18 years of age.

Exclusion Criteria:

1. Patient has multiple dAVFs to be treated.
2. Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
3. Patient does not give consent to the collection and processing of data required for centralized monitoring

3. Any condition that could prevent patient follow up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events and assessment of neurological status at 1 month after each embolization	Neurological assessment by mRS	1 month
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)	Cure rate assessment by Angiography	3-6 months after last embolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events and assessment of neurological status	Neurological assessment by mRS	3-6 months after last embolization
Improvement in the quality of life of the patient and changes in patients symptoms	Assessed by Quality of Life Questionnaire EQ 5D	3-6 months after last embolization

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Collaborators: ClinSearch

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): March 11, 2020
• Study Completion (Actual): March 11, 2020

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula; Central Nervous System Vascular Malformations
• Other Study ID Numbers: dAVF-Phil Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No