Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Medtronic Neurovascular Clinical Affairs112 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Arteriovenous Malformations

Interventions

Apollo™ Onyx™ Delivery Micro CatheterDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Radiology Imaging Associates, P.C.

Englewood, Colorado, United States

Brigham's & Women Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Secondary Outcomes

Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days

Rate of premature (unintentional) catheter tip detachment

Time frame: 30 days

Number of Participants With Intentional Catheter Tip Detachment at 30 Days

Rate of intentional catheter tip detachment

Time frame: 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

Time frame: 30 days

Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days

Rate of catheter/tip leakage from detachment zone

Time frame: 30 days

Number of Participants With Catheter-related Adverse Events at 30 Days

Incidence of catheter-related adverse events at 30 days

Time frame: 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)

Data from ClinicalTrials.gov

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