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New treatment option for Arterio-venous Fistula
Official title PHIL® Embolic System Pediatric IDE
ClinicalTrials.gov ID: NCT03731000
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Subject is \<22 years of age
- Subject and legally authorized representative are willing and capable of complying with all study protocol requirements, including specified...
- 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...
You likely can't join if
- 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...
- Subject has existing severe or advanced comorbid conditions which significantly increase general anesthesia and/ or surgical risk
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.