Back to resultsPHIL® Embolic System Pediatric IDE
Primary Purpose
Arterio-venous Fistula, Intracranial Arteriovenous Malformations
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PHIL® device
Sponsored by
About this trial
This is an interventional treatment trial for Arterio-venous Fistula focused on measuring Pediatric
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 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
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PHIL® device
Arm Description
Using device
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Incidence of angiographic cure
Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.
Incidence of new-onset permanent morbidity
New-onset permanent morbidity up to 12 month follow-up
Incidence of new-onset Intracranial hemorrhage (ICH)
New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up
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.
Incidence of device-related adverse events at procedure
Incidence of device-related adverse events at procedure at Day 1
Incidence of device-related adverse events at 30 days
Incidence of device-related adverse events at 30 days.
Incidence of device-related mortality
Device-related mortality 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.
Incidence of cranial neuropathy
Incidence of cranial neuropathy up to 12 months follow-up
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
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).
Number of procedures
Number of procedures required to treat the fistula at 3-6 month follow-up
Procedure time
Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions)
Dosage of Radiation exposure
Radiation exposure time
Injected volume of PHIL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03731000
Brief Title
PHIL® Embolic System Pediatric IDE
Official Title
Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alejandro Berenstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-venous Fistula, Intracranial Arteriovenous Malformations
Keywords
Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PHIL® device
Arm Type
Experimental
Arm Description
Using device
Intervention Type
Device
Intervention Name(s)
PHIL® device
Intervention Description
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
Primary Outcome Measure Information:
Title
Proportion of participants with neurological death or major ipsilateral stroke
Description
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
Time Frame
12 months
Title
Proportion of participants with angiographic occlusion
Description
Proportion of subjects with Angiographic occlusion of the pre-specified target vessel intended for treatment at procedure following completion of treatment
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Incidence of angiographic cure
Description
Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.
Time Frame
up to 12 months
Title
Incidence of new-onset permanent morbidity
Description
New-onset permanent morbidity up to 12 month follow-up
Time Frame
up to 12 months
Title
Incidence of new-onset Intracranial hemorrhage (ICH)
Description
New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up
Time Frame
up to 12 months
Title
Number of significant technical events
Description
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.
Time Frame
up to 12 months
Title
Incidence of device-related adverse events at procedure
Description
Incidence of device-related adverse events at procedure at Day 1
Time Frame
Day 1 during procedure
Title
Incidence of device-related adverse events at 30 days
Description
Incidence of device-related adverse events at 30 days.
Time Frame
at 30 days
Title
Incidence of device-related mortality
Description
Device-related mortality at 30 days
Time Frame
at 30 days
Title
Incidence of procedure related adverse events
Description
Procedure related adverse events including complications of arterial puncture, contrast-induced nephropathy, renal and anesthesia-related complications.
Time Frame
up to 12 months
Title
Incidence of cranial neuropathy
Description
Incidence of cranial neuropathy up to 12 months follow-up
Time Frame
up to 12 months
Title
Pediatric NIH Stroke Scale (PedNIHSS)
Description
PedNIHSS - 11 item instrument measuring levels of impairment on a scale of 0-42 with higher score demonstrating higher levels of impairment
Time Frame
at 12 months
Title
The Pediatric Stroke Outcome Measure (PSOM)
Description
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).
Time Frame
at 12 months
Title
Number of procedures
Description
Number of procedures required to treat the fistula at 3-6 month follow-up
Time Frame
up to 6 months
Title
Procedure time
Description
Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions)
Time Frame
average of 3-4 hours
Title
Dosage of Radiation exposure
Time Frame
average of 60 minutes
Title
Radiation exposure time
Time Frame
average of 60 minutes
Title
Injected volume of PHIL
Time Frame
at time of procedure, average of 3-4 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sukaina Davdani
Phone
(212) 241-2524
Email
sukaina.davdani@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Genadry
Phone
(212) 241-9018
Email
lisa.genadry2@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Berenstein, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johanna Fifi, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Fifi, MD
12. IPD Sharing Statement
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PHIL® Embolic System Pediatric IDE
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