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Clinical Trials/NCT03467542
NCT03467542
Completed
Not Applicable

PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas

Microvention-Terumo, Inc.1 site in 1 country64 target enrollmentStarted: August 24, 2018Last updated:
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ConditionsArteriovenous Dural Fistula

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Microvention-Terumo, Inc.
Enrollment
64
Locations
1
Primary Endpoint
Subjects With Neurological Death or Ipsilateral Stroke
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 will be treated with PHIL® Liquid Embolic material.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
22 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Subjects With Neurological Death or Ipsilateral Stroke

Time Frame: 30 days

Reported incidences of death or ipsilateral stroke

Secondary Outcomes

  • Technical Events During the PHIL Embolization Procedure(s)(During the procedure)
  • Device-related Adverse Events(30 days)

Investigators

Sponsor
Microvention-Terumo, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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