Status:
COMPLETED
PHIL in the Treatment of Intracranial dAVF.
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Arteriovenous Dural Fistula
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03467542
Start Date
August 24 2018
End Date
December 12 2022
Last Update
December 31 2024
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208