Arteriovenous Dural FistulaPHIL dAVFNCT03467542
PHIL in the Treatment of Intracranial dAVF.
A study testing PHIL® Liquid Embolic System in people with Arteriovenous Dural Fistula, run by Microvention-Terumo, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Arteriovenous Dural Fistula
- What is being tested?
- PHIL® Liquid Embolic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
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.
- Conditions
- Arteriovenous Dural Fistula
- Being tested
- PHIL® Liquid Embolic System
- Keywords
- Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
- Medical subject headings
- Central Nervous System Vascular Malformations, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHIL® Liquid Embolic SystemDevice
The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
| Study group | Role | What they receive |
|---|---|---|
| dAVF treatment | Experimental | PHIL® Liquid Embolic System Receives: Device: PHIL® Liquid Embolic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With Neurological Death or Ipsilateral Stroke
Reported incidences of death or ipsilateral stroke
Measured: 30 days
Secondary outcomes (2)
Technical Events During the PHIL Embolization Procedure(s)
Reported incidences of technical events with PHIL device
Measured: During the procedure
Device-related Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start24 Aug 2018
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arteriovenous Dural FistulaStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J Mocco, MD, Principal investigator, Mt. SinaiAlan Boulos, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467542
- Sponsor's protocol ID
- CL11005
- Acronym
- PHIL dAVF
- Status last verified
- May 2024
- First submitted
- 6 Mar 2018
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
- ClinicalTrials.gov ID
- NCT03467542
- Acronym / sponsor ID
- PHIL dAVF / CL11005
- Conditions
- Arteriovenous Dural Fistula
- Keywords
- Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dAVF treatment | Experimental | Device: PHIL® Liquid Embolic SystemPHIL® Liquid Embolic System |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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® Liquid Embolic SystemThe PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) | Device | dAVF treatment |
Primary outcome
Subjects With Neurological Death or Ipsilateral Stroke
Time frame: 30 days
Reported incidences of death or ipsilateral stroke
2 secondary outcomes
Technical Events During the PHIL Embolization Procedure(s)
Time frame: During the procedure
Device-related Adverse Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
J Mocco, MD principal investigator
Mt. Sinai
Alan Boulos, MD principal investigator
Albany Medical College
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® Liquid Embolic System in people with Arteriovenous Dural Fistula, run by Microvention-Terumo, Inc. 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 6 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: finished, as of the sponsor's last update on 31 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects With Neurological Death or Ipsilateral Stroke (time frame: 30 days). 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 31 Dec 2024.