Safety of Apollo Micro Catheter in Pediatric Patients

Brain Arteriovenous Malformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085278
• Other study ID #: APL01
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Arteriovenous Malformation
• Brain Vascular Malformations
• Congenital Abnormalities
• Hemangioma
• Vascular Malformations
• Vein of Galen Malformation
• Vein of Galen Malformations

Intervention

Device:
• Apollo Micro Catheter device
Detachable Tip Micro catheter

Locations

Country	Name	City	State
United States	St.Luke's-Roosevelt Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Epub 2009 Dec 28. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 24 hours after embolization
Secondary	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.	Within 24 hours after embolization
Secondary	Incidence of migration of the detached catheter tip.	Defined by an observed change in position of the detached tip during post embolization imaging.	Within 24 hours after embolization
Secondary	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).	At one year post procedure
Secondary	Incidence of catheter/tip leakage from the detachment zone.		At one year post procedure
Secondary	Incidence of migration of the detached catheter tip	Defined by an observed change in position of the detached tip during the post embolization imaging.	At one year post procedure