Using the PHIL® Embolic System to treat pediatric brain vascular conditions
Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
This study is testing if the PHIL® Embolic System can safely and effectively treat brain blood vessel problems in children and young adults under 22.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03731000 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the PHIL® Embolic System in treating intracranial dural arteriovenous fistulas in pediatric patients. It is a prospective, single-center, single-arm study that collects data on outcomes from subjects under 22 years of age. The study aims to determine how well the PHIL® device works either alone or in combination with other treatments for these vascular malformations. Participants will be monitored for safety and potential benefits throughout the study.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 22 years old with intracranial dural arteriovenous fistulas suitable for treatment with the PHIL® device.
Not a fit: Patients with an intracranial mass, those undergoing radiation therapy for head or neck cancer, or those with specific allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing complex brain vascular conditions in children.
How similar studies have performed: While the PHIL® Embolic System has been approved as a Humanitarian Use Device, this specific application in pediatric patients is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alejandro Berenstein, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sukaina Davdani
- Email: sukaina.davdani@mountsinai.org
- Phone: (212) 241-2524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.