PHIL dAVF Study:
Evaluation in the Endovascular Treatment of Intracranial Dural AVF
PHIL™ Liquid Embolic System
"The PHIL-dAVF study provides evidence about the efficacy and safety of PHIL in the treatment of intracranial dAVFs, with outcomes comparable to existing liquid embolic agents reported in the literature."
- Patients
67
- Countries
France, Spain, UK, Sweden, Denmark
- Clinical Centers
13
- Design
Single arm prospective
- Scope
All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL used with or without other embolization products.
- Purpose
Assess safety and efficacy of PHIL used with or without other embolization products (cyanoacrylate glue, coils, balloon, etc.) in endovascular embolization of dAVF.
Endpoints
Efficacy: Cure rate and clinical course of the patient stability/improvement/deterioration at 3-6 months after last embolization compared to baseline
Cure rate assessed by Angiography validated by Corelab
Safety: Number of adverse events and assessment of neurological status (mRS) at 1 month after each embolization compared to baseline
Efficacy results
At 3-6 months post last embolization session:
Complete angiographic cure rate: 86.9%
Safety results
AE: 4.5%
At 1 month post embolization session:
Transient functional deterioration: 4.5% – all resolved by the last follow-up.
At 3-6 months post embolization session:
Transient functional deterioration: 0%
Mortality: 0%
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT03317821
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