Clinical trial NCT03317821: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF
Official title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dural Arteriovenous Fistula
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2017-10-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events and assessment of neurological status at 1 month after each embolization
timeFrame: 1 month
measure: Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
timeFrame: 3-6 months after last embolization
Secondary outcomes:
measure: Number of adverse events and assessment of neurological status
timeFrame: 3-6 months after last embolization
measure: Improvement in the quality of life of the patient and changes in patients symptoms
timeFrame: 3-6 months after last embolization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University
city: Bordeaux
country: France
facility: CHU Pellgrin
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Limoges
country: France
facility: CHU Limoges
city: Paris
country: France
facility: La Fondation Rothschild
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet
city: Barcelona
country: Spain
facility: Hospital Universitario General de Catalunya
city: Madrid
country: Spain
facility: Hospital Nuestra Senora del Rosario
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Umeå
country: Sweden
facility: Universitetssjukhus Umea
city: Uppsala
country: Sweden
facility: Uppsala University
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
References: