Safety of Apollo Micro Catheter in Pediatric Patients

Brief Title

Safety of Apollo Micro Catheter in Pediatric Patients

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 Description

      -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.
    


Study Type

Interventional


Primary Outcome

The study's primary endpoint is the incidence of catheter entrapment.

Secondary Outcome

 Incidence of unintentional catheter tip detachment.

Condition

Brain Arteriovenous Malformation

Intervention

Apollo Micro Catheter device

Study Arms / Comparison Groups

 Apollo Group
Description:  Apollo Micro catheter device

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

February 2014

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  Female who is pregnant or lactating.

          -  Current participation in another investigational drug or device study.

          -  Subject has a brain tumor or other malignancy
      

Gender

All

Ages

N/A - 21 Years

Accepts Healthy Volunteers

No

Contacts

Ahmed Otokiti, MBBS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02085278

Organization ID

APL01


Responsible Party

Sponsor

Study Sponsor

St. Luke's-Roosevelt Hospital Center


Study Sponsor

Ahmed Otokiti, MBBS, Study Director, St. Luke's-Roosevelt Hospital Center


Verification Date

January 2019