PHIL® Embolic System Pediatric IDE

Arterio-venous Fistula Clinical Trial

Official title:

Study of PHIL® Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas in the Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03731000
• Other study ID #: GCO 18-1298
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Sukaina Davdani
• Phone: (212) 241-2524
• Email: sukaina.davdani[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• Arteriovenous Malformations
• Fistula
• Intracranial Arteriovenous Malformations

Intervention

Device:
• PHIL® device
Using PHIL® device for treatment of intracranial dural arteriovenous fistulas

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Alejandro Berenstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Incidence of angiographic cure	Angiographic cure of the target dAVF, defined as complete obliteration of dAVF flow following final treatment.	up to 12 months
Secondary	Incidence of new-onset permanent morbidity	New-onset permanent morbidity up to 12 month follow-up	up to 12 months
Secondary	Incidence of new-onset Intracranial hemorrhage (ICH)	New-onset Intracranial hemorrhage (ICH) up to 12 month follow0up	up to 12 months
Secondary	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
Secondary	Incidence of device-related adverse events at procedure	Incidence of device-related adverse events at procedure at Day 1	Day 1 during procedure
Secondary	Incidence of device-related adverse events at 30 days	Incidence of device-related adverse events at 30 days.	at 30 days
Secondary	Incidence of device-related mortality	Device-related mortality at 30 days	at 30 days
Secondary	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
Secondary	Incidence of cranial neuropathy	Incidence of cranial neuropathy up to 12 months follow-up	up to 12 months
Secondary	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
Secondary	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
Secondary	Number of procedures	Number of procedures required to treat the fistula at 3-6 month follow-up	up to 6 months
Secondary	Procedure time	Procedure time (defined as first to last fluoroscopic or digital subtraction angiographic acquisitions)	average of 3-4 hours
Secondary	Dosage of Radiation exposure		average of 60 minutes
Secondary	Radiation exposure time		average of 60 minutes
Secondary	Injected volume of PHIL		at time of procedure, average of 3-4 hours