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Brain Arteriovenous MalformationNCT02085278

Safety of Apollo Micro Catheter in Pediatric Patients

A study testing Apollo Micro Catheter device in people with Brain Arteriovenous Malformation and Brain Vascular Malformations, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
Apollo Micro Catheter device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Feb 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St.Luke's-Roosevelt Hospital

    New York, New York, 10019

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Apollo Micro Catheter device
Keywords
arteriovenous malformation, Brain, AVM, Onyx, Micro catheter, catheter entrapment,, Embolization, Vein Of Galen
Medical subject headings
Central Nervous System Vascular Malformations, Vein of Galen Malformations, Arteriovenous Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apollo Micro Catheter deviceDevice

    Detachable Tip Micro catheter

Study groups in NCT02085278
Study groupRoleWhat they receive
Apollo GroupExperimentalApollo Micro catheter device
Receives: Device: Apollo Micro Catheter device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within 24 hours after embolization

Secondary outcomes (5)

  1. 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.

    Measured: Within 24 hours after embolization

  2. Incidence of migration of the detached catheter tip.

    Defined by an observed change in position of the detached tip during post embolization imaging.

    Measured: Within 24 hours after embolization

  3. 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).

    Measured: At one year post procedure

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

    Measured: At one year post procedure

  5. Incidence of migration of the detached catheter tip

    Defined by an observed change in position of the detached tip during the post embolization imaging.

    Measured: At one year post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02085278
Sponsor's protocol ID
APL01
Status last verified
Jan 2019
First submitted
4 Mar 2014
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12823868

  • 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.

    PubMed 21990795

  • 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.

    PubMed 20465885

  • 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.

    PubMed 21990504

Questions about this trial

What is this clinical trial studying?

A study testing Apollo Micro Catheter device in people with Brain Arteriovenous Malformation and Brain Vascular Malformations, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The study's primary endpoint is the incidence of catheter entrapment. (time frame: Within 24 hours after embolization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02085278, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

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