PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Microvention-Terumo, Inc.
- Enrollment
- 70
- Locations
- 16
- Primary Endpoint
- Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Any condition that could prevent patient follow up.
Outcomes
Primary Outcomes
Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated)
Time Frame: 3-6 months after last embolization
Cure rate assessment by Angiography
Number of adverse events and assessment of neurological status at 1 month after each embolization
Time Frame: 1 month
Neurological assessment by mRS
Secondary Outcomes
- 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)