Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.

Detailed Description
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This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.

Official Title
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Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Conditions
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Arteriovenous Malformations

Intervention / Treatment
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* Device: Apollo™ Onyx™ Delivery Micro Catheter


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. The Subject has a confirmed diagnosis of a brain AVM. 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. The Subject agrees to and is capable of completing all study-required procedures. Exclusion Criteria: Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease. The Subject has a bleeding disorder. The Subject is not a candidate for the use of vasodilators.
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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AVM treatment<br>Apollo™ Onyx™ Delivery Micro Catheter | Device: Apollo™ Onyx™ Delivery Micro Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Catheter-related Adverse Events at 30 Days | Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature | 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days | Rate of premature (unintentional) catheter tip detachment | 30 days | 
| Number of Participants With Intentional Catheter Tip Detachment at 30 Days | Rate of intentional catheter tip detachment | 30 days | 
| Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days | Rate of migration of the retained catheter tip post embolization | 30 days | 
| Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days | Rate of catheter/tip leakage from detachment zone | 30 days | 
| Number of Participants With Catheter-related Adverse Events at 30 Days | Incidence of catheter-related adverse events at 30 days | 30 days | 
| Number of Participants With Catheter-related Adverse Events at 12 Months | Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint) | 12 months | 
| Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months | Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AVM, Brain Diseases, Apollo, Onyx, Arteriovenous malformation, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter