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This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dAVF treatment | Experimental | PHIL® Liquid Embolic System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHIL® Liquid Embolic System | Device | The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Neurological Death or Ipsilateral Stroke | Reported incidences of death or ipsilateral stroke | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Events During the PHIL Embolization Procedure(s) | Reported incidences of technical events with PHIL device | During the procedure |
| Device-related Adverse Events | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Mocco, MD | Mt. Sinai | Principal Investigator |
| Alan Boulos, MD | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Albany | New York | 12208 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | dAVF Treatment | PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | dAVF Treatment | PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects With Neurological Death or Ipsilateral Stroke | Reported incidences of death or ipsilateral stroke | Posted | Count of Participants | Participants | 30 days |
|
|
6 months after last embolization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | dAVF Treatment | PHIL® Liquid Embolic System PHIL® Liquid Embolic System: The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysacusis | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gash | Terumo Neuro | 714-247-8000 | robert.gash@microvention.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 3, 2023 | Oct 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2023 | Oct 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020785 | Central Nervous System Vascular Malformations |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Technical Events During the PHIL Embolization Procedure(s) | Reported incidences of technical events with PHIL device | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| Secondary | Device-related Adverse Events | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 1 |
| 62 |
| 5 |
| 62 |
| 27 |
| 62 |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Diplopia | Eye disorders | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | Non-systematic Assessment |
|
| Swelling face | General disorders | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Radiation alopecia | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vascular site access hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary retention post operative | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vascular access site pseudo aneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary tract procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vascular access site pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Procedural headache | Nervous system disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Facial paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Cerebral vasoconstriction | Nervous system disorders | Non-systematic Assessment |
|
| Facial paresis | Nervous system disorders | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | Non-systematic Assessment |
|
| Papillo edema | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
The Principal Investigator may publish the results if Sponsor has not published within eighteen (18) months after FDA approval of the Trial Devices.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |