PHIL® Embolic System for Arteriovenous Malformations

Overseen By Cynthia Nguyen

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Alejandro Berenstein

Disqualifiers: Pregnancy, Cancer, Autoimmune, Infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: Day 1 during procedure

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and benefits of the PHIL® Embolic System, a medical device for treating intracranial dural arteriovenous fistulas (DAVFs), which are abnormal connections between arteries and veins in the brain. The study collects data on the device's effectiveness for patients with these specific brain conditions. It is ideal for individuals under 22 with a DAVF suitable for treatment with this system or those previously treated for DAVF. Participants should not have major health issues that increase surgical risks or allergies to medications used in the procedure. As an unphased trial, this study allows patients to contribute to groundbreaking research that could enhance future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PHIL® Embolic System is safe for treating intracranial dural arteriovenous fistulas?

Research has shown that the PHIL® Embolic System is safe for treating certain blood vessel issues in the brain, known as intracranial dural arteriovenous fistulas (DAVFs). Studies have found that PHIL is as safe as other similar treatments. Specifically, one study reported few complications during or after the procedure when using the PHIL System. The FDA approved the PHIL System in 2016 for special use, aiming to enhance the safety of these treatments. Overall, PHIL appears to be well-tolerated by patients needing treatment for DAVFs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PHIL® Embolic System is unique because it offers a novel approach to treating arteriovenous malformations (AVMs) by using a liquid embolic agent designed to block abnormal blood vessels more effectively. Unlike traditional methods that might use particles or coils, the PHIL® system is designed to provide a smoother and more controlled delivery, potentially reducing the risk of complications and improving precision. Researchers are excited about this treatment because it could offer a more efficient and safer way to manage AVMs, which are complex and challenging to treat with existing options.

What evidence suggests that the PHIL® Embolic System is effective for treating intracranial dural arteriovenous fistulas?

Research has shown that the PHIL® Embolic System effectively treats abnormal blood vessel connections in the brain, known as intracranial dural arteriovenous fistulas (dAVFs). Studies have found that PHIL matches the effectiveness of other liquid agents used to block unusual blood flow in the brain. The system is praised for its ability to reach deep into the problem area due to its lower viscosity. Early results indicate that PHIL successfully closes the targeted blood vessel issues. Overall, the PHIL Embolic System is considered both effective and safe for these treatments. ^{1 3 4 5 6}

Who Is on the Research Team?

Tomoyoshi Shigematsu, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Alejandro Berenstein, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for children under 22 with intracranial dural arteriovenous fistulas (dAVFs) suitable for embolization using the PHIL® device. They must have consent from a legal representative, be able to follow study procedures, and not weigh less than 2.5kg. Those with severe health risks, allergies to certain substances like DMSO or iodine, pregnant females, or those with life-threatening illnesses other than dAVFs cannot participate.

Inclusion Criteria

Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified follow-up period

I am under 22 years old.

I have a brain vessel malformation suitable for a specific treatment or have been treated before for it.

Exclusion Criteria

I have a bleeding disorder, my INR is over 1.5, or I refuse blood transfusions.

I am at risk for kidney damage from contrast dye or a rare skin condition.

I have a tumor in my brain or am receiving radiation for cancer in my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PHIL® Embolic System for the treatment of intracranial dural arteriovenous fistulas

Day 1 during procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neurological outcomes and angiographic cure

12 months

Multiple visits (in-person and virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PHIL® Embolic System

Trial Overview The PHIL® Embolic System is being tested for safety and potential benefits in treating intracranial dural arteriovenous fistulas in pediatric patients. This system has been approved by the FDA as a Humanitarian Use Device and this study aims to gather more data on its effectiveness.

How Is the Trial Designed?

Group I: PHIL® device Experimental Treatment 1 Intervention

Using device

PHIL® Embolic System is already approved in United States for the following indications:

Approved in United States as PHIL Embolic System for:

• Intracranial dural arteriovenous fistulas

Who Is Running the Clinical Trial?

Alejandro Berenstein

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The use of precipitating hydrophobic injectable liquid (PHIL) as a new liquid embolic agent in a 60-year-old male with a large arteriovenous malformation (AVM) demonstrated excellent penetration into small blood vessels during endovascular embolization, which is crucial for effective treatment.

PHIL showed advantages over existing embolic agents, including reduced glare on imaging and less skin pigmentation, making it a promising alternative for pre-operative embolization of large AVMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel use of precipitating hydrophobic injectable liquid (PHIL) in pre-operative angioembolisation of a large posterior auricular arteriovenous malformation. Chu, C., Tan, THL., Ng, KS., et al.[2023]

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]

In a study involving 24 embolization procedures in pigs, the new low-viscosity liquid embolic agent PHIL 25% demonstrated effective distal penetration and adequate visibility, making it a promising option for endovascular embolization.

PHIL 25% low viscosity and another agent, Squid 12, showed significantly lower reflux compared to standard PHIL 25%, indicating better control during the embolization process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of a New Version of the Liquid Embolic Agent PHIL with Extra-Low-Viscosity in an Endovascular Embolization Model. Vollherbst, DF., Otto, R., Hantz, M., et al.[2020]

In a study involving 27 patients with cerebral arteriovenous malformations, the new liquid embolic agent, precipitating hydrophobic injectable liquid, achieved total obliteration in 52% of cases during a single treatment session, indicating promising efficacy.

The treatment was associated with a 22.2% complication rate but no recorded mortality, suggesting that while the agent is generally safe, further research is necessary to fully establish its safety and effectiveness compared to other embolic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with precipitating hydrophobic injectable liquid in cerebral arteriovenous malformations. Sirakov, SS., Sirakov, A., Minkin, K., et al.[2020]

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]

In a study involving five patients with cerebral arteriovenous malformations (AVMs), the new embolic material Precipitating Hydrophobic Injectable Liquid (PHIL) was used successfully, with two patients achieving complete cure of their AVMs.

There were no procedural complications reported during the treatment, indicating that PHIL is a safe option for embolization, although one patient experienced a seizure post-procedure without any signs of hemorrhage on a CT scan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with Precipitating Hydrophobic Injectable Liquid (PHIL) in treating cerebral AVMs. Samaniego, EA., Kalousek, V., Abdo, G., et al.[2019]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6378517/

Initial experience with precipitating hydrophobic injectable ... In our initial experience, precipitating hydrophobic injectable liquid has acceptable clinical outcome comparable to other liquid embolic agents. Although this ...

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. neurointervention.org neurointervention.org/journal/view.php?number=376

PHIL and Squid Embolization of Cerebral Arteriovenous ... PHIL and Squid are effective and safe liquid embolic agents for endovascular embolization of cerebral AVM, achieving satisfactory nidal obliteration rates.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT03467542/Prot_000.pdf

phildavf:study of phil®embolic system in PHIL® 25% liquid embolic will travel more distally and penetrate deeper into the nidus due to its lower viscosity. Page 30. PHIL DAVF: Study of ...

5. cvirendovasc.springeropen.com cvirendovasc.springeropen.com/articles/10.1186/s42155-019-0059-z

Precipitating hydrophobic injectable liquid (PHIL) embolic ... This case presents a technical report of a uterine AVM treated successfully with transcatheter UAE using precipitating hydrophobic injectable liquid (PHIL) ...

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.