Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Alejandro Berenstein
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Proportion of participants with neurological death or major ipsilateral stroke
Overview
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.
Detailed Description
Study design:The study is a prospective, single-center, single-arm, clinical study evaluating outcomes in pediatric subjects with intracranial dural arteriovenous fistulas treated with PHIL® device.
Study purpose: To evaluate the safety and probable benefit of MicroVention, Inc. PHIL® Liquid Embolic material in the treatment of intracranial dural arteriovenous fistulas, alone or as an adjunctive treatment for dAVFs.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Proportion of participants with neurological death or major ipsilateral stroke
Time Frame: 12 months
The proportion of subjects with neurological death or major ipsilateral stroke (defined as a major stroke within the vascular distribution of the vessel targeted for treatment) within 12 months following completion of treatment, reported as one composite data variable
Proportion of participants with angiographic occlusion
Time Frame: up to 12 months
Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment
Secondary Outcomes
- Injected volume of PHIL(at time of procedure, average of 3-4 hours)
- Incidence of new-onset permanent morbidity(up to 12 months)
- Number of significant technical events(up to 12 months)
- Procedure time(average of 3-4 hours)
- Incidence of new-onset Intracranial hemorrhage (ICH)(up to 12 months)
- Incidence of device-related mortality(at 30 days)
- Incidence of angiographic cure(up to 12 months)
- Radiation exposure time(average of 60 minutes)
- Incidence of device-related adverse events at procedure(Day 1 during procedure)
- Incidence of device-related adverse events at 30 days(at 30 days)
- Incidence of procedure related adverse events(up to 12 months)
- Pediatric NIH Stroke Scale (PedNIHSS)(at 12 months)
- Dosage of Radiation exposure(average of 60 minutes)
- Incidence of cranial neuropathy(up to 12 months)
- The Pediatric Stroke Outcome Measure (PSOM)(at 12 months)
- Number of procedures(up to 6 months)
Investigators
Alejandro Berenstein
Professor
Icahn School of Medicine at Mount Sinai