N/A
N=62
PHIL in the Treatment of Intracranial dAVF.
Arteriovenous Dural Fistula
Bottom Line
View on ClinicalTrials.gov: NCT03467542 ↗Enrolled (actual)
62
Serious AEs
8.1%
Results posted
Dec 2024
Primary outcome: Primary: Subjects With Neurological Death or Ipsilateral Stroke — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PHIL® Liquid Embolic System (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Microvention-Terumo, Inc.
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Neurological Death or Ipsilateral Stroke |
— | — |
| SECONDARY Technical Events During the PHIL Embolization Procedure(s) |
— | — |
| SECONDARY Device-related Adverse Events |
1 | — |
Summary
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.
Eligibility Criteria
Inclusion Criteria
- Age 22 - 80 years.
- Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
- Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
- Subject has an intracranial dAVF
Exclusion Criteria
- Subject having multiple dAVFs to be treated.
- Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
- Subject has known allergies to dimethylsulfoxide, iodine.
- Subject is currently participating in another clinical study
- Female subject is currently pregnant.
- Subject has co-morbid conditions that may limit survival to less than 24 months.
Data sourced from ClinicalTrials.gov (NCT03467542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.