PHIL in the Treatment of Intracranial dAVF.

(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

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a special liquid to treat patients with abnormal blood vessel connections in the brain, who have few safe treatment options. The liquid hardens and blocks these abnormal vessels, stopping the problematic blood flow.

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 safety data exists for the PHIL Liquid Embolic System?

The PHIL Liquid Embolic System has been studied for safety in various procedures, including cranial and peripheral embolizations. In a study of 26 patients with cranial conditions, safety was assessed by monitoring adverse events and clinical status at a 3-month follow-up. Another study involving 178 patients evaluated its safety in peripheral procedures, indicating it is generally safe when used under proper guidance. ^{1 2 3 4 5}

How does the PHIL Liquid Embolic System treatment differ from other treatments?

The PHIL Liquid Embolic System is unique because it is a non-adhesive liquid embolic agent that causes fewer imaging artifacts compared to other agents like Onyx, making it easier to monitor treatment progress. It also allows for rapid injection without skin discoloration, which is beneficial in both neurological and non-neurological procedures. ^{1 2 4 5 6}

Research Team

J Mocco, MD

Principal Investigator

Mt. Sinai

Alan Boulos, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

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

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

Treatment Details

Interventions

• PHIL® Liquid Embolic System

Participant Groups

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+

Findings from Research

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 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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Phil Embolic Agent for Bleeding in Non-Neurological Interventions. [2021]

2. Turkey pubmed.ncbi.nlm.nih.gov

Introducing PHIL (precipitating hydrophobic injectable liquid) - a new embolic agent for the body interventional radiologist. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

PHIL® (precipitating hydrophobic injectable liquid): retrospective multicenter experience on 178 patients in peripheral embolizations. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Embolization of Intracranial Dural Arteriovenous Fistulas Using PHIL Liquid Embolic Agent in 26 Patients: A Multicenter Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Imaging artifacts of Onyx and PHIL on conventional CT, cone-beam CT and MRI in an animal model. [2019]

6. England 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. [2017]