Clinical trial NCT02378883: Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Official title: Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Malformations
Keywords: Apollo
Onyx
Arteriovenous malformation
AVM
Onyx™ Liquid Embolic System
Apollo™ Onyx™ Delivery Microcatheter
Brain Diseases
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Catheter-related Adverse Events at 30 Days
timeFrame: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Secondary outcomes:
measure: Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
timeFrame: 30 days
measure: Number of Participants With Intentional Catheter Tip Detachment at 30 Days
timeFrame: 30 days
measure: Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
timeFrame: 30 days
measure: Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
timeFrame: 30 days
measure: Number of Participants With Catheter-related Adverse Events at 30 Days
timeFrame: 30 days
measure: Number of Participants With Catheter-related Adverse Events at 12 Months
timeFrame: 12 months
measure: Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Radiology Imaging Associates, P.C.
state: Colorado
city: Boston
country: United States
facility: Brigham's & Women Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Mohammed A Aziz-Sultan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.