Safety of Apollo Micro Catheter in Pediatric Patients
Primary Purpose
Brain Arteriovenous Malformation, Brain Vascular Malformations, Vein of Galen Malformation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apollo Micro Catheter device
Sponsored by
About this trial
This is an interventional device feasibility trial for Brain Arteriovenous Malformation focused on measuring arteriovenous malformation, Brain, AVM, Onyx, Micro catheter, catheter entrapment,, Embolization, Vein Of Galen
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
Sites / Locations
- St.Luke's-Roosevelt Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apollo Group
Arm Description
Apollo Micro catheter device
Outcomes
Primary Outcome Measures
The study's primary endpoint is the incidence of catheter entrapment.
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.
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.
Defined by an observed change in position of the detached tip during post embolization imaging.
Incidence of catheter/procedure-related adverse events.
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.
Incidence of migration of the detached catheter tip
Defined by an observed change in position of the detached tip during the post embolization imaging.
Full Information
NCT ID
NCT02085278
First Posted
March 4, 2014
Last Updated
January 22, 2019
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT02085278
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Arteriovenous Malformation, Brain Vascular Malformations, Vein of Galen Malformation
Keywords
arteriovenous malformation, Brain, AVM, Onyx, Micro catheter, catheter entrapment,, Embolization, Vein Of Galen
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apollo Group
Arm Type
Experimental
Arm Description
Apollo Micro catheter device
Intervention Type
Device
Intervention Name(s)
Apollo Micro Catheter device
Intervention Description
Detachable Tip Micro catheter
Primary Outcome Measure Information:
Title
The study's primary endpoint is the incidence of catheter entrapment.
Description
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
Time Frame
Within 24 hours after embolization
Secondary Outcome Measure Information:
Title
Incidence of unintentional catheter tip detachment.
Description
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.
Time Frame
Within 24 hours after embolization
Title
Incidence of migration of the detached catheter tip.
Description
Defined by an observed change in position of the detached tip during post embolization imaging.
Time Frame
Within 24 hours after embolization
Title
Incidence of catheter/procedure-related adverse events.
Description
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).
Time Frame
At one year post procedure
Title
Incidence of catheter/tip leakage from the detachment zone.
Time Frame
At one year post procedure
Title
Incidence of migration of the detached catheter tip
Description
Defined by an observed change in position of the detached tip during the post embolization imaging.
Time Frame
At one year post procedure
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Otokiti, MBBS
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alejandro Berenstein, M.D
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12823868
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.
Results Reference
background
PubMed Identifier
21990795
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.
Results Reference
background
PubMed Identifier
20465885
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.
Results Reference
background
PubMed Identifier
21990504
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.
Results Reference
background
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Safety of Apollo Micro Catheter in Pediatric Patients
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