Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-18

Study Completion Date

2018-02-20

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.

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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.

Conditions

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Arteriovenous Malformations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVM treatment

Apollo™ Onyx™ Delivery Micro Catheter

Group Type OTHER

Apollo™ Onyx™ Delivery Micro Catheter

Intervention Type DEVICE

Interventions

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Apollo™ Onyx™ Delivery Micro Catheter

Intervention Type DEVICE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No