Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Medtronic

Status

Completed

Conditions

Arteriovenous Malformations

Treatments

Device: Apollo™ Onyx™ Delivery Micro Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT02378883

NV-APL001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

112 patients

Sex

All

Volunteers

No Healthy Volunteers

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.