PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Dural Arteriovenous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317821
• Other study ID #: dAVF-Phil Registry
• Status: Completed
• Start date: September 18, 2017
• Est. completion date: March 11, 2020

Study information

• Verified date: July 2021
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dural Arteriovenous Fistula
• Fistula

Locations

Country	Name	City	State
Denmark	Rigshospitalet University	Copenhagen
France	CHU Pellgrin	Bordeaux
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CHU Limoges	Limoges
France	La Fondation Rothschild	Paris
France	Hôpital Pierre Paul Riquet	Toulouse
Spain	Hospital Universitario General de Catalunya	Barcelona
Spain	Hospital Nuestra Senora del Rosario	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Málaga
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Sweden	Universitetssjukhus Umea	Umeå
Sweden	Uppsala University	Uppsala
United Kingdom	University Hospital Birmingham	Birmingham
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Charing Cross Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.	ClinSearch

Countries where clinical trial is conducted

Denmark,  France,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events and assessment of neurological status at 1 month after each embolization	Neurological assessment by mRS	1 month
Primary	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	Number of adverse events and assessment of neurological status	Neurological assessment by mRS	3-6 months after last embolization
Secondary	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