CompletedNot Applicable

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Denmark, France70 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 range18 Years

SexALL

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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

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