Safety of Apollo Micro Catheter in Pediatric Patients

Completed · Not applicable

Conditions studied: Brain Arteriovenous Malformation, Brain Vascular Malformations, Vein of Galen Malformation

In brief

This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).

Key facts

Study ID

NCT02085278

Run by

St. Luke's-Roosevelt Hospital Center

People needed

10

Starts

2014-02-01

Expected to finish

2015-06-01

Last updated by the study team

2019-01-25

Who can join

Age: any, up to 21. 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.
• Subject's age is ≤ 21 years.
• The subject has a confirmed diagnosis of brain arteriovenous malformation in the cerebral cortex, cerebellum or dura mater that is indicated for endovascular embolization with Onyx™ LES or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Systems and where the use of Apollo Embolization Delivery Micro Catheter may or may not be indicated for surgical resection.
• 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 with the exception of new born babies with Vein of Galen malformation with cardiopulmonary failure where no other treatment option remains.
• The subject agrees to and is capable of completing all study required procedures

You may not qualify if…

• Female who is pregnant or lactating.
• Current participation in another investigational drug or device study.
• Subject has a brain tumor or other malignancy

Where it is running

• St.Luke's-Roosevelt Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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