An observational study in Dural Arteriovenous Fistula, sponsored by Microvention-Terumo, Inc.. Completed at 16 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.
Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Observational
The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.
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.
Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
First submitted after Microvention-Terumo, Inc. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of adverse events and assessment of neurological status at 1 month after each embolization
Neurological assessment by mRS
Time frame: 1 month
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
Cure rate assessment by Angiography
Time frame: 3-6 months after last embolization
Number of adverse events and assessment of neurological status
Neurological assessment by mRS
Time frame: 3-6 months after last embolization
Improvement in the quality of life of the patient and changes in patients symptoms
Assessed by Quality of Life Questionnaire EQ 5D
Time frame: 3-6 months after last embolization
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Central Nervous System Vascular Malformations