Safety of Apollo Micro Catheter in Pediatric Patients

NCT02085278 | Completed

• 1 other identifier: APL01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of unintentional catheter tip detachment.

  Within 24 hours after embolization

• Incidence of migration of the detached catheter tip.

  Within 24 hours after embolization

• Incidence of catheter/procedure-related adverse events.

  At one year post procedure

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

  At one year post procedure

• Incidence of migration of the detached catheter tip

  At one year post procedure

Study Arms (1)

Apollo Group

EXPERIMENTAL

Apollo Micro catheter device

Device: Apollo Micro Catheter device

Interventions

Apollo Micro Catheter device DEVICE

Detachable Tip Micro catheter

Apollo Group

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Female who is pregnant or lactating.
• Current participation in another investigational drug or device study.
• Subject has a brain tumor or other malignancy

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St.Luke's-Roosevelt Hospital

New York, New York, 10019, United States

Location

Related 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. doi: 10.1227/01.neu.0000068700.68238.84.

  PMID: 12823868 BACKGROUND

• 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.

  PMID: 21990795 BACKGROUND

• 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.

  PMID: 20465885 BACKGROUND

• 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.

  PMID: 21990504 BACKGROUND

MeSH Terms

Conditions

Central Nervous System Vascular Malformations; Vein of Galen Malformations; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Arteriovenous Malformations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Intracranial Arterial Diseases

Study Officials

• Ahmed Otokiti, MBBS

  St. Luke's-Roosevelt Hospital Center

  STUDY DIRECTOR

• Alejandro Berenstein, M.D

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 12, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (1)