Arterio-venous FistulaNCT03731000
PHIL® Embolic System Pediatric IDE
A study testing PHIL® device in people with Arterio-venous Fistula and Intracranial Arteriovenous Malformations, run by Alejandro Berenstein at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Arterio-venous Fistula, Intracranial Arteriovenous Malformations
- What is being tested?
- PHIL® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
- Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
Show all 14Show fewer
- Evidence of active infection at the time of treatment.
- Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions.
- Subject weighs ≤ 2.5kg Angiographic
- Subject has severe calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, or access to the lesion with the microcatheter.
- Contra-indication to DSA, CT scan or MRI/ MRA
- History of intracranial vasospasm not responsive to medical therapy
- Extra-cranial stenosis or parent vessel stenosis > 50% proximal to the target lesion to be treated.
- Subject has a propensity to contrast induced renal injury or a potential to nephrogenic systemic fibrosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Tomoyoshi Shigematsu
About this study
Official title: Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
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.
Read the detailed description
Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.
Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.
- Being tested
- PHIL® device
- Keywords
- Pediatric
- Medical subject headings
- Arteriovenous Fistula, Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHIL® deviceDevice
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
| Study group | Role | What they receive |
|---|---|---|
| PHIL® device | Experimental | Using device Receives: Device: PHIL® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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
Measured: up to 12 months
Secondary outcomes (16)
Incidence of angiographic cure
Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.
Measured: up to 12 months
Incidence of new-onset permanent morbidity
New-onset permanent morbidity up to 12 month follow-up
Measured: up to 12 months
Incidence of new-onset Intracranial hemorrhage (ICH)
New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up
Measured: up to 12 months
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.
Measured: up to 12 months
Incidence of device-related adverse events at procedure
Incidence of device-related adverse events at procedure at Day 1
Measured: Day 1 during procedure
Incidence of device-related adverse events at 30 days
Incidence of device-related adverse events at 30 days.
Measured: at 30 days
Incidence of device-related mortality
Device-related mortality at 30 days
Measured: at 30 days
Incidence of procedure related adverse events
Procedure related adverse events including complications of arterial puncture, contrast-induced nephropathy, renal and anesthesia-related complications.
Measured: up to 12 months
Incidence of cranial neuropathy
Incidence of cranial neuropathy up to 12 months follow-up
Measured: up to 12 months
Pediatric NIH Stroke Scale (PedNIHSS)
PedNIHSS - 11 item instrument measuring levels of impairment on a scale of 0-42 with higher score demonstrating higher levels of impairment
Measured: at 12 months
The Pediatric Stroke Outcome Measure (PSOM)
PSOM - measures stroke outcomes across 115 test items. On completion of the PSOM examination, the neurologist scores a Summary of Impressions containing 5 subscales: right sensorimotor, left sensorimotor (each with subcategories), language production, language comprehension, and cognitive/behavioral. Subscale scoring is 0 (no deficit), 0.5 (mild deficit, normal function), 1 (moderate deficit, decreased function), or 2 (severe deficit, missing function). The PSOM total score is the sum of the 5 subscale scores and ranges from 0 (no deficit) to 10 (maximum deficit).
Measured: at 12 months
Number of procedures
Number of procedures required to treat the fistula at 3-6 month follow-up
Measured: up to 6 months
Procedure time
Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions)
Measured: average of 3-4 hours
Dosage of Radiation exposure
Measured: average of 60 minutes
Radiation exposure time
Measured: average of 60 minutes
Injected volume of PHIL
Measured: at time of procedure, average of 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start16 Apr 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alejandro Berenstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alejandro Berenstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Alejandro Berenstein, MD, Principal investigator, Icahn School of Medicine at Mount SinaiTomoyoshi Shigematsu, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731000
- Sponsor's protocol ID
- GCO 18-1298
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2018
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
- ClinicalTrials.gov ID
- NCT03731000
- Acronym / sponsor ID
- GCO 18-1298
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alejandro BerensteinUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.
Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| PHIL® device | Experimental | Device: PHIL® deviceUsing device |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Subject has an acute or chronic life-threatening illness other than the neurological disease to be treated in this study including but not limited to any malignancy or debilitating autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHIL® deviceUsing PHIL® device for treatment of intracranial dural arteriovenous fistulas | Device | PHIL® device |
Primary outcome
Proportion of participants with neurological death or major ipsilateral stroke
Time frame: 12 months
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
Proportion of participants with angiographic occlusion
Time frame: up to 12 months
Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment
16 secondary outcomes
Incidence of angiographic cure
Time frame: up to 12 months
Incidence of new-onset permanent morbidity
Time frame: up to 12 months
Incidence of new-onset Intracranial hemorrhage (ICH)
Time frame: up to 12 months
Number of significant technical events
Time frame: up to 12 months
Incidence of device-related adverse events at procedure
Time frame: Day 1 during procedure
Incidence of device-related adverse events at 30 days
Time frame: at 30 days
Incidence of device-related mortality
Time frame: at 30 days
Incidence of procedure related adverse events
Time frame: up to 12 months
Incidence of cranial neuropathy
Time frame: up to 12 months
Pediatric NIH Stroke Scale (PedNIHSS)
Time frame: at 12 months
The Pediatric Stroke Outcome Measure (PSOM)
Time frame: at 12 months
Number of procedures
Time frame: up to 6 months
Procedure time
Time frame: average of 3-4 hours
Dosage of Radiation exposure
Time frame: average of 60 minutes
Radiation exposure time
Time frame: average of 60 minutes
Injected volume of PHIL
Time frame: at time of procedure, average of 3-4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Arterio-venous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Not yet recruiting
Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization
Supraclavicular Plexus Block Procedure (SCPB), ESRD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Berenstein, MD principal investigator
Icahn School of Medicine at Mount Sinai
Tomoyoshi Shigematsu, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHIL® device in people with Arterio-venous Fistula and Intracranial Arteriovenous Malformations, run by Alejandro Berenstein at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sukaina Davdani ((212) 241-2524, sukaina.davdani@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with neurological death or major ipsilateral stroke (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.