Clinical trial NCT02085278: Safety of Apollo Micro Catheter in Pediatric Patients
Official title: Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Arteriovenous Malformation
Brain Vascular Malformations
Vein of Galen Malformation
Keywords: arteriovenous malformation
Brain
AVM
Onyx
Micro catheter
catheter entrapment,
Embolization
Vein Of Galen
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 10
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: The study's primary endpoint is the incidence of catheter entrapment.
timeFrame: Within 24 hours after embolization
Secondary outcomes:
measure: Incidence of unintentional catheter tip detachment.
timeFrame: Within 24 hours after embolization
measure: Incidence of migration of the detached catheter tip.
timeFrame: Within 24 hours after embolization
measure: Incidence of catheter/procedure-related adverse events.
timeFrame: At one year post procedure
measure: Incidence of catheter/tip leakage from the detachment zone.
timeFrame: At one year post procedure
measure: Incidence of migration of the detached catheter tip
timeFrame: At one year post procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: St.Luke's-Roosevelt Hospital
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Ahmed Otokiti, MBBS
role: STUDY_DIRECTOR
affiliation: St. Luke's-Roosevelt Hospital Center
name: Alejandro Berenstein, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SD, Marcellus ML, Marks MP, Levy RP, Do HM, Steinberg GK. Multimodality treatment of giant intracranial arteriovenous malformations. Neurosurgery. 2003 Jul;53(1):1-11; discussion 11-3. doi: 10.1227/01.neu.0000068700.68238.84.
citation: Walcott BP, Gerrard JL, Nogueira RG, Nahed BV, Terry AR, Ogilvy CS. Microsurgical retrieval of an endovascular microcatheter trapped during Onyx embolization of a cerebral arteriovenous malformation. J Neurointerv Surg. 2011 Mar;3(1):77-9. doi: 10.1136/jnis.2010.002733. Epub 2010 Oct 5.
citation: Santillan A, Zink W, Knopman J, Riina H, Gobin YP. Balloon-assisted technique for trapped microcatheter retrieval following onyx embolization. A case report. Interv Neuroradiol. 2009 Dec;15(4):453-5. doi: 10.1177/159101990901500414. Epub 2009 Dec 28.
citation: Newman CB, Park MS, Kerber CW, Levy ML, Barr JD, Pakbaz RS. Over-the-catheter retrieval of a retained microcatheter following Onyx embolization: a technical report. J Neurointerv Surg. 2012 Jul;4(4):e13. doi: 10.1136/neurintsurg-2011-010040. Epub 2011 Jun 16.