Apollo™ Onyx™ Delivery Micro Catheter Post Market Safety Study



Status:Completed
Conditions:Cardiology, Women's Studies, Hematology
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology, Reproductive
Healthy:No
Age Range:Any
Updated:9/21/2018
Start Date:May 18, 2015
End Date:February 20, 2018

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


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.
We found this trial at
2
sites
Brigham's & Women Hospital
Boston, Massachusetts 02115
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Boston, MA
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Radiology Imaging Associates
Englewood, Colorado 80112
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Englewood, CO
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