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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHIL® device | Experimental | Using device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHIL® device | Device | Using PHIL® device for treatment of intracranial dural arteriovenous fistulas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with neurological death or major ipsilateral stroke | 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 | 12 months |
| Proportion of participants with angiographic occlusion | Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of angiographic cure | Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment. | up to 12 months |
| Incidence of new-onset permanent morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukaina Davdani | Contact | (212) 241-2524 | sukaina.davdani@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Berenstein, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Tomoyoshi Shigematsu, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Single Group
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New-onset permanent morbidity up to 12 month follow-up
| up to 12 months |
| Incidence of new-onset Intracranial hemorrhage (ICH) | New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up | up to 12 months |
| Number of significant technical events | Clinically significant technical events during the PHIL embolization procedure(s) including but not limited to reflux of embolic material, migration of the embolic material, catheter entrapment or damage, and vessel dissection. | up to 12 months |
| Incidence of device-related adverse events at procedure | Incidence of device-related adverse events at procedure at Day 1 | Day 1 during procedure |
| Incidence of device-related adverse events at 30 days | Incidence of device-related adverse events at 30 days. | at 30 days |
| Incidence of device-related mortality | Device-related mortality at 30 days | at 30 days |
| Incidence of procedure related adverse events | Procedure related adverse events including complications of arterial puncture, contrast-induced nephropathy, renal and anesthesia-related complications. | up to 12 months |
| Incidence of cranial neuropathy | Incidence of cranial neuropathy up to 12 months follow-up | up to 12 months |
| Pediatric NIH Stroke Scale (PedNIHSS) | PedNIHSS - 11 item instrument measuring levels of impairment on a scale of 0-42 with higher score demonstrating higher levels of impairment | at 12 months |
| The Pediatric Stroke Outcome Measure (PSOM) | PSOM - measures stroke outcomes across 115 test items. On completion of the PSOM examination, the neurologist scores a Summary of Impressions containing 5 subscales: right sensorimotor, left sensorimotor (each with subcategories), language production, language comprehension, and cognitive/behavioral. Subscale scoring is 0 (no deficit), 0.5 (mild deficit, normal function), 1 (moderate deficit, decreased function), or 2 (severe deficit, missing function). The PSOM total score is the sum of the 5 subscale scores and ranges from 0 (no deficit) to 10 (maximum deficit). | at 12 months |
| Number of procedures | Number of procedures required to treat the fistula at 3-6 month follow-up | up to 6 months |
| Procedure time | Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions) | average of 3-4 hours |
| Dosage of Radiation exposure | average of 60 minutes |
| Radiation exposure time | average of 60 minutes |
| Injected volume of PHIL | at time of procedure, average of 3-4 hours |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D020765 | Intracranial Arterial Diseases |