PHIL® Embolic System Pediatric IDE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorAlejandro Berenstein
About this trial
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs.
The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is <22 years of age
Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period.
Subject's legally authorized representative(s) must sign and date an IRB approved written informed consent prior to initiation of any study procedure
Subject has an intracranial dAVF that is deemed appropriate for embolization with PHIL without significantly increased risk to collateral or adjacent territories, OR subject has been previously treated with other embolic materials for dAVF.
Disqualifiers
Subject presents with an intracranial mass or is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
Subject has known allergies to DMSO (dimethyl sulfoxide), iodine or heparin.
Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
Female subject is currently pregnant.
Trial design
Design model
Single group
Treatments tested in this trial
PHIL® device
DeviceUsing PHIL® device for treatment of intracranial dural arteriovenous fistulas
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: PHIL® deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with neurological death or major ipsilateral stroke
The proportion of subjects with neurological death or major ipsilateral stroke (defined as a major stroke within the vascular distribution of the vessel targeted for treatment) within 12 months following completion of treatment, reported as one composite data variable
Time frame
12 months2
Proportion of participants with angiographic occlusion
Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment
Time frame
up to 12 monthsSecondary outcomes
1
Incidence of angiographic cure
Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.
Time frame
up to 12 months2
Incidence of new-onset permanent morbidity
New-onset permanent morbidity up to 12 month follow-up
Time frame
up to 12 months3
Incidence of new-onset Intracranial hemorrhage (ICH)
New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up
Time frame
up to 12 months4
Number of significant technical events
Clinically significant technical events during the PHIL embolization procedure(s) including but not limited to reflux of embolic material, migration of the embolic material, catheter entrapment or damage, and vessel dissection.
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alejandro Berenstein
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov