Safety of Apollo Micro Catheter in Pediatric Patients
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).
Brain Arteriovenous Malformation
Brain Vascular Malformations
Vein of Galen Malformation
Device: Apollo Micro Catheter device
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations|
- The study's primary endpoint is the incidence of catheter entrapment. [ Time Frame: Within 24 hours after embolization ] [ Designated as safety issue: Yes ]The study's primary endpoint is the incidence of catheter entrapment. Catheter entrapment entails any part of the Apollo Micro catheter Delivery Device, excluding the catheter tip, being inadvertently left within the vasculature at the end of the procedure
- Incidence of unintentional catheter tip detachment. [ Time Frame: Within 24 hours after embolization ] [ Designated as safety issue: Yes ]Defined by the separation of the detachment joint during the procedure either during navigation, prior to embolization completion, or upon catheter retrieval when distal tip is not entrapped in Onyx cast.
- Incidence of migration of the detached catheter tip. [ Time Frame: Within 24 hours after embolization ] [ Designated as safety issue: Yes ]Defined by an observed change in position of the detached tip during post embolization imaging.
- Incidence of catheter/procedure-related adverse events. [ Time Frame: At one year post procedure ] [ Designated as safety issue: Yes ]The adverse events include but not limited to vascular occlusion (a sudden blockage of a blood vessel usually with a blood clot), vascular thrombosis (acute and subacute) (blood clots in a vessel that break loose and enter another vessel), allergic reactions, thrombocytopenia (significant decrease in red blood cell clotting factors), Death, neurologic deterioration (nervous system decline) including stroke and death, pulmonary embolization or complications (blockage of blood vessels in the lung), perforation or dissection of the vessel (tear of the blood vessel).
- Incidence of catheter/tip leakage from the detachment zone. [ Time Frame: At one year post procedure ] [ Designated as safety issue: Yes ]
- Incidence of migration of the detached catheter tip [ Time Frame: At one year post procedure ] [ Designated as safety issue: Yes ]Defined by an observed change in position of the detached tip during the post embolization imaging.
|Study Start Date:||February 2014|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Apollo Group
Apollo Micro catheter device
Device: Apollo Micro Catheter device
Detachable Tip Micro catheter
-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02085278
|United States, New York|
|New York, New York, United States, 10019|
|Study Director:||Ahmed Otokiti, MBBS||St. Luke's-Roosevelt Hospital Center|
|Principal Investigator:||Alejandro Berenstein, M.D||St. Luke's-Roosevelt Hospital Center|