Safety of Apollo Micro Catheter in Pediatric Patients

Study Overview
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Brief Summary
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This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).

Detailed Description
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-Why is this study being done? The purpose of this study is to evaluate the safety of the Apollo Embolization Delivery Micro Catheter device (device that looks like a long thin hallow tube) when used in Pediatric patients with vascular malformations. The Apollo Onyx Delivery Micro Catheter device is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Apollo Onyx™ Delivery Micro Catheter device is not approved for use in the U.S, although it is widely used and approved for use in Europe (CE0297). This clinical study is sponsored by Dr. Alejandro Berenstein of St.Luke's-Roosevelt Hospital, New York who is also the principal Investigator of the study. Total duration of study is up to 30 months with approximately an 18 months enrollment period. Patients follow up period is up to 12 months upon enrollment.

Official Title
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Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations

Conditions
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Brain Arteriovenous Malformation, Brain Vascular Malformations, Vein of Galen Malformation

Intervention / Treatment
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* Device: Apollo Micro Catheter device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject or subject's legally authorized representative has signed and dated an informed Consent Form. Subject's age is ≤ 21 years. The subject has a confirmed diagnosis of brain arteriovenous malformation in the cerebral cortex, cerebellum or dura mater that is indicated for endovascular embolization with Onyx™ LES or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Systems and where the use of Apollo Embolization Delivery Micro Catheter may or may not be indicated for surgical resection. The subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization. The subject has a life expectancy of at least 1 year with the exception of new born babies with Vein of Galen malformation with cardiopulmonary failure where no other treatment option remains. The subject agrees to and is capable of completing all study required procedures Exclusion Criteria: Female who is pregnant or lactating. Current participation in another investigational drug or device study. Subject has a brain tumor or other malignancy

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apollo Group<br>Apollo Micro catheter device | Device: Apollo Micro Catheter device<br>* Detachable Tip Micro catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study's primary endpoint is the incidence of catheter entrapment. | The study's primary endpoint is the incidence of catheter entrapment. Catheter entrapment entails any part of the Apollo Micro catheter Delivery Device, excluding the catheter tip, being inadvertently left within the vasculature at the end of the procedure | Within 24 hours after embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of unintentional catheter tip detachment. | Defined by the separation of the detachment joint during the procedure either during navigation, prior to embolization completion, or upon catheter retrieval when distal tip is not entrapped in Onyx cast. | Within 24 hours after embolization | 
| Incidence of migration of the detached catheter tip. | Defined by an observed change in position of the detached tip during post embolization imaging. | Within 24 hours after embolization | 
| Incidence of catheter/procedure-related adverse events. | The adverse events include but not limited to vascular occlusion (a sudden blockage of a blood vessel usually with a blood clot), vascular thrombosis (acute and subacute) (blood clots in a vessel that break loose and enter another vessel), allergic reactions, thrombocytopenia (significant decrease in red blood cell clotting factors), Death, neurologic deterioration (nervous system decline) including stroke and death, pulmonary embolization or complications (blockage of blood vessels in the lung), perforation or dissection of the vessel (tear of the blood vessel). | At one year post procedure | 
| Incidence of catheter/tip leakage from the detachment zone. |  | At one year post procedure | 
| Incidence of migration of the detached catheter tip | Defined by an observed change in position of the detached tip during the post embolization imaging. | At one year post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteriovenous malformation, Brain, AVM, Onyx, Micro catheter, catheter entrapment,, Embolization, Vein Of Galen