PHIL for Brain Fistulas

(PHIL dAVF Trial)

Overseen By Jennifer Jelf

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Microvention-Terumo, Inc.

Disqualifiers: Multiple dAVFs, Allergy to contrast, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During the procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PHIL® Liquid Embolic System, a medical device for individuals with intracranial dural arteriovenous fistulas (dAVFs). dAVFs are abnormal connections between blood vessels in the brain that can cause headaches, seizures, or other symptoms. The trial aims to determine if this treatment can safely and effectively assist those with this condition. Individuals diagnosed with a dAVF who can commit to follow-up visits might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PHIL® Liquid Embolic System is safe for treating dAVFs?

Research has shown that the PHIL® Liquid Embolic System is generally safe for treating intracranial dural arteriovenous fistulas (dAVFs). Studies have found its safety comparable to other liquid materials used for this purpose. In past trials, patients treated with PHIL experienced no more side effects than those treated with other methods. The treatment comes in different strengths, enabling doctors to choose the best option for each patient. This flexibility can enhance safety by tailoring the treatment to individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PHIL® Liquid Embolic System is unique because it offers a different approach to treating intracranial dural arteriovenous fistulas (dAVFs). Unlike the traditional embolization treatments that often use materials like coils or particles, PHIL® uses a liquid embolic agent that can be precisely delivered to the target site. This liquid form allows for better penetration and potentially more effective sealing of the abnormal blood vessels. Researchers are excited about PHIL® because its unique composition and delivery method might offer improved outcomes and reduced risk of complications compared to existing options.

What evidence suggests that the PHIL® Liquid Embolic System might be an effective treatment for dAVF?

Studies have shown that the PHIL® Liquid Embolic System effectively treats certain brain blood vessel issues called intracranial dural arteriovenous fistulas (dAVFs). Research indicates that PHIL is as effective as other liquid treatments for these conditions. This liquid helps block abnormal blood flow in the brain. Previous studies confirm its safety and effectiveness, making it a reliable choice for patients with dAVFs. Participants in this trial will receive the PHIL system, considered both safe and effective for this specific type of brain issue. ^{1 2 3 6 7}

Who Is on the Research Team?

J Mocco, MD

Principal Investigator

Mt. Sinai

Alan Boulos, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject has an intracranial dAVF

Age 22 - 80 years.

Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

All patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material

During the procedure

Follow-up

Participants are monitored for neurological death or ipsilateral stroke

30 days

What Are the Treatments Tested in This Trial?

Interventions

• PHIL® Liquid Embolic System

How Is the Trial Designed?

Group I: dAVF treatment Experimental Treatment 1 Intervention

PHIL® Liquid Embolic System

Who Is Running the Clinical Trial?

Microvention-Terumo, Inc.

Lead Sponsor

Trials

32

Recruited

7,000+

Published Research Related to This Trial

In a preliminary study involving eight patients with cranial and spinal dural arteriovenous fistulas (DAVFs), the new liquid embolic agent PHIL successfully achieved complete angiographic exclusion in seven cases, demonstrating its potential efficacy as a treatment option.

No significant complications or neurological deterioration were reported, suggesting that PHIL may be a safe alternative to existing liquid embolic agents, although further research is needed to confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with the liquid embolic material agent PHIL (Precipitating Hydrophobic Injectable Liquid) in treating cranial and spinal dural arteriovenous fistulas: technical note. Leyon, JJ., Chavda, S., Thomas, A., et al.[2017]

In a study of 26 patients with cranial dural arteriovenous fistulas, the new liquid embolic agent PHIL achieved a high rate of complete occlusion (77%) and demonstrated safety with only one adverse event reported.

PHIL's effectiveness and short-term results are comparable to the established agent Onyx, but it offers advantages such as easier preparation and better visualization on imaging, making it a promising option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolization of Intracranial Dural Arteriovenous Fistulas Using PHIL Liquid Embolic Agent in 26 Patients: A Multicenter Study. Lamin, S., Chew, HS., Chavda, S., et al.[2022]

Precipitating hydrophobic injectable liquid (PHIL) is a new embolic agent that is compatible with dimethyl sulfoxide (DMSO) and offers unique advantages for interventional radiology, including rapid injection and no skin discoloration.

PHIL has been effectively used in various procedures such as trauma embolization, pseudoaneurysm embolization, and tumor embolization, making it a valuable addition to the tools available for body interventional radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing PHIL (precipitating hydrophobic injectable liquid) - a new embolic agent for the body interventional radiologist. Prashar, A., Butt, S., Shaida, N.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7963645/

Embolization of Intracranial Dural Arteriovenous Fistulas ... The aim of the study was to retrospectively assess the efficacy and safety of Precipitating Hydrophobic Injectable Liquid (PHIL), a new nonadhesive liquid ...

2. jnis.bmj.com jnis.bmj.com/content/early/2025/01/08/jnis-2024-022630

Efficacy and safety of the PHIL embolic agent in ... The PHIL-dAVF study provides evidence about the efficacy and safety of PHIL in the treatment of intracranial dAVFs, with outcomes comparable to existing liquid ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39778931/

results of the PHIL-dAVF study The PHIL-dAVF study provides evidence about the efficacy and safety of PHIL in the treatment of intracranial dAVFs, with outcomes comparable to existing liquid ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03467542

NCT03467542 | PHIL in the Treatment of Intracranial dAVF. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material. Official Title. PHIL dAVF: Study of PHIL® Embolic System ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15910199241288897

Safety and efficacy of newer liquid embolic agents Squid ... Squid and PHIL are safe and effective embolic agents for treatment of dAVFs and cAVMs. Introduction. Since the advent of endovascular treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559774/

Safety and efficacy of newer liquid embolic agents squid ... Newer liquid embolics, Squid (Balt) and PHIL (MicroVention), aim to improve the safety and efficacy of EVT of dAVFs and cAVMs.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03317821

PHIL Evaluation in the Endovascular Treatment of ... The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.