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Safety of Apollo Micro Catheter in Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT02085278
First received: March 4, 2014
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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).

-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.


Condition Intervention
Brain Arteriovenous Malformation (AVM)
Brain Vascular Malformations
Vein of Galen Malformation
Device: Apollo Micro Catheter device

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apollo Group
Apollo Micro catheter device
Device: Apollo Micro Catheter device
Detachable Tip Micro catheter

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085278

Contacts
Contact: Ahmed U Otokiti, M.B,B.S, CCRP 212-636-3217 aotokiti@chpnet.org
Contact: Peter Rappa, MBA 212-636-3221 prappa@chpnet.org

Locations
United States, New York
St.Luke's-Roosevelt Hospital Recruiting
New York, New York, United States, 10019
Contact: Ahmed Otokiti, M.B,B.S CCRP    212-636-3217    aotokiti@chpnet.org   
Contact: Peter Rappa, MBA    212-636-3221    prappa@chpnet.org   
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Study Director: Ahmed Otokiti, M.B,B.S CCRP St. Luke's-Roosevelt Hospital Center
Principal Investigator: Alejandro Berenstein, M.D St. Luke's-Roosevelt Hospital Center
  More Information

Additional Information:
Publications:
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT02085278     History of Changes
Other Study ID Numbers: APL01
Study First Received: March 4, 2014
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Luke's-Roosevelt Hospital Center:
arteriovenous malformation
Brain
AVM
Onyx
Micro catheter
catheter entrapment,
Embolization
Vein Of Galen

Additional relevant MeSH terms:
Arteriovenous Malformations
Central Nervous System Vascular Malformations
Congenital Abnormalities
Vascular Malformations
Vein of Galen Malformations
Cardiovascular Abnormalities
Intracranial Arteriovenous Malformations
Nervous System Malformations
Hemangioma
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014