Clinical Trial: Safety of Apollo Micro Catheter in Pediatric Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations

Brief Summary: 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).

Detailed Summary:

-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.


Sponsor: St. Luke's-Roosevelt Hospital Center

Current Primary Outcome: The study's primary endpoint is the incidence of catheter entrapment. [ Time Frame: Within 24 hours after embolization ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of unintentional catheter tip detachment. [ Time Frame: Within 24 hours after embolization ]
    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 ]
    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 ]
    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 ]
  • Incidence of migration of the detached catheter tip [ Time Frame: At one year post procedure ]
    Defined by an observed change in position of the detached tip during the post embolization imaging.


Original Secondary Outcome: Same as current

Information By: St. Luke's-Roosevelt Hospital Center

Dates:
Date Received: March 4, 2014
Date Started: February 2014
Date Completion:
Last Updated: August 5, 2015
Last Verified: August 2015