Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Completed · Not applicable

Conditions studied: Arteriovenous Malformations

In brief

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.

Key facts

Study ID

NCT02378883

Run by

Medtronic Neurovascular Clinical Affairs

People needed

112

Starts

2015-05-18

Expected to finish

2018-02-20

Last updated by the study team

2019-04-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radiology Imaging Associates, P.C. — Englewood, Colorado, United States
• Brigham's & Women Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.