Safety of Apollo Micro Catheter in Pediatric Patients

January 22, 2019 updated by: St. Luke's-Roosevelt Hospital Center

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • St.Luke's-Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apollo Group
Apollo Micro catheter device
Device: Apollo Micro Catheter device
Detachable Tip Micro catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 24 hours after embolization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 24 hours after embolization
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.
Within 24 hours after embolization
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).
At one year post procedure
Incidence of catheter/tip leakage from the detachment zone.
Time Frame: At one year post procedure
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.
At one year post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Investigators

  • Study Director: Ahmed Otokiti, MBBS, St. Luke's-Roosevelt Hospital Center
  • Principal Investigator: Alejandro Berenstein, M.D, St. Luke's-Roosevelt Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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