Brain Arteriovenous Malformation Clinical Trial
Official title:
Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations
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).
-Why is this study being done?
The purpose of this study is to evaluate the safety of the Apollo Embolization Delivery Micro
Catheter device (device that looks like a long thin hallow tube) when used in Pediatric
patients with vascular malformations.
The Apollo Onyx Delivery Micro Catheter device is manufactured by Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular. Apollo Onyx™ Delivery Micro Catheter device is not approved for use
in the U.S, although it is widely used and approved for use in Europe (CE0297).
This clinical study is sponsored by Dr. Alejandro Berenstein of St.Luke's-Roosevelt Hospital,
New York who is also the principal Investigator of the study. Total duration of study is up
to 30 months with approximately an 18 months enrollment period. Patients follow up period is
up to 12 months upon enrollment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02314377 -
Bevacizumab Therapy for Brain Arteriovenous Malformation
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Phase 1 | |
| Recruiting |
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