NCT02378883

Brief Summary

The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 18, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

February 24, 2015

Results QC Date

March 1, 2019

Last Update Submit

April 4, 2019

Conditions

Arteriovenous Malformations

Keywords

ApolloOnyxArteriovenous malformationAVMOnyx™ Liquid Embolic SystemApollo™ Onyx™ Delivery MicrocatheterBrain Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Catheter-related Adverse Events at 30 Days

    Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature

    30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Secondary Outcomes (7)

  • Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days

    30 days

  • Number of Participants With Intentional Catheter Tip Detachment at 30 Days

    30 days

  • Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days

    30 days

  • Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days

    30 days

  • Number of Participants With Catheter-related Adverse Events at 30 Days

    30 days

  • +2 more secondary outcomes

Study Arms (1)

AVM treatment

OTHER

Apollo™ Onyx™ Delivery Micro Catheter

Device: Apollo™ Onyx™ Delivery Micro Catheter

Interventions

Apollo™ Onyx™ Delivery Micro CatheterDEVICE
AVM treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The Subject or Subject's legally authorized representative has signed and dated an informed consent form.
  • The Subject has a confirmed diagnosis of a brain AVM.
  • 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.
  • The Subject agrees to and is capable of completing all study-required procedures.

You may not qualify if:

  • Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.
  • The Subject has a bleeding disorder.
  • The Subject is not a candidate for the use of vasodilators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiology Imaging Associates, P.C.

Englewood, Colorado, 80112, United States

Location

Brigham's & Women Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Meyers PM, Fifi JT, Cockroft KM, Miller TR, Given CA, Zomorodi AR, Jagadeesan BD, Mokin M, Kan P, Yao TL, Diaz O, Huddle D, Bellon RJ, Seinfeld J, Polifka AJ, Fiorella D, Chitale RV, Kvamme P, Morrow JT, Singer J, Wakhloo AK, Puri AS, Deshmukh VR, Hanel RA, Gonzalez LF, Woo HH, Aziz-Sultan MA. Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study. J Neurointerv Surg. 2021 Oct;13(10):935-941. doi: 10.1136/neurintsurg-2020-016830. Epub 2021 Feb 1.

    PMID: 33526480DERIVED

MeSH Terms

Conditions

Arteriovenous MalformationsBrain Diseases

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Study was completed.

Results Point of Contact

Title
Darren Lacour, Sr. Manager, Clinical Project Management
Organization
Medtronic Neurovascular
darren.j.lacour@medtronic.com
949-680-1274

Study Officials

  • Mohammed A Aziz-Sultan, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 4, 2015

Study Start

May 18, 2015

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

April 29, 2019

Results First Posted

April 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.

Locations

US(2)