CompletedNot Applicable

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Denmark, France, Spain70 participantsStarted 2017-09-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of adverse events and assessment of neurological status at 1 month after each embolization

Timeframe: 1 month

Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)

Timeframe: 3-6 months after last embolization

Trial details

NCT IDNCT03317821

SponsorMicrovention-Terumo, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-03-11

View on ClinicalTrials.gov More Dural Arteriovenous Fistula trials