| NCT ID | NCT03731000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alejandro Berenstein |
| Condition | Arterio-venous Fistula |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2019-04-16 |
| Primary Completion | 2027-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
Eligibility 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 pregna