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NCT Number: NCT02085278

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).

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Key information

Conditions

Brain Arteriovenous Malformation Arteriovenous Malformations Brain Diseases Brain Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Nervous System Diseases Nervous System Malformations Vascular Diseases Vascular Malformations Vein of Galen Malformation Vein of Galen Malformations

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Luke's-Roosevelt Hospital

New York, 10019, United States

About this study

-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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apollo Micro Catheter device

Device

Detachable Tip Micro catheter

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Incidence of catheter/tip leakage from the detachment zone.

    Time frame: At one year post procedure

  5. 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.

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2014
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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