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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach

5 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

September 18, 2017

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed

Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

October 18, 2017

Last Update Submit

July 28, 2021

Conditions

Dural Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

Number of adverse events and assessment of neurological status
3-6 months after last embolization
Improvement in the quality of life of the patient and changes in patients symptoms
3-6 months after last embolization

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
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).
Patient is at least 18 years of age.

You may not qualify if:

Patient has multiple dAVFs to be treated.
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.
Patient does not give consent to the collection and processing of data required for centralized monitoring
\. Any condition that could prevent patient follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Microvention-Terumo, Inc.lead
ClinSearchcollaborator

Study Sites (16)

Rigshospitalet University

Copenhagen, 2100, Denmark

Location

CHU Pellgrin

Bordeaux, 33000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU Limoges

Limoges, 87000, France

Location

La Fondation Rothschild

Paris, 75010, France

Location

Hôpital Pierre Paul Riquet

Toulouse, 31059, France

Location

Hospital Universitario General de Catalunya

Barcelona, 08190, Spain

Location

Hospital Nuestra Senora del Rosario

Madrid, 28006, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Universitetssjukhus Umea

Umeå, 90746, Sweden

Location

Uppsala University

Uppsala, 75185, Sweden

Location

University Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Vascular Malformations

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 12 Months
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 23, 2017

Study Start

September 18, 2017

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing: Will not share

Locations

FR(5)ES(5)DK(1)SE(2)GB(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations