Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02378883

Enrollment

112

Registered

2015-03-04

Start date

2015-05-18

Completion date

2018-02-20

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Malformations

Keywords

Apollo, Onyx, Arteriovenous malformation, AVM, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter, Brain Diseases

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.

Interventions

DEVICEApollo™ Onyx™ Delivery Micro Catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Catheter-related Adverse Events at 30 Days	30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter	Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature

Secondary

Measure	Time frame	Description
Number of Participants With Intentional Catheter Tip Detachment at 30 Days	30 days	Rate of intentional catheter tip detachment
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days	30 days	Rate of migration of the retained catheter tip post embolization
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days	30 days	Rate of catheter/tip leakage from detachment zone
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days	30 days	Rate of premature (unintentional) catheter tip detachment
Number of Participants With Catheter-related Adverse Events at 12 Months	12 months	Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months	12 months	Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Number of Participants With Catheter-related Adverse Events at 30 Days	30 days	Incidence of catheter-related adverse events at 30 days

Countries

United States

Participant flow

Participants by arm

Arm	Count
APOLLO The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.	112
Total	112

Withdrawals & dropouts

Period	Reason	FG000
12 Months Follow-Up	Death	2
12 Months Follow-Up	Lost to Follow-up	3
30 Day Follow-Up	Death	1
30 Day Follow-Up	Missed Visit	2
30 Day Follow-Up	Physician Decision	2
30 Day Follow-Up	Withdrawal by Subject	1
Enrollment	Attempt to use Apollo was not performed	3
Enrollment	Subject did not meet Inclusion criteria	6

Baseline characteristics

Characteristic	APOLLO
Age, Continuous	44.1 years STANDARD_DEVIATION 17.6
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	3 Participants
Race (NIH/OMB) Black or African American	17 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants
Race (NIH/OMB) White	79 Participants
Region of Enrollment United States	112 participants
Sex: Female, Male Female	49 Participants
Sex: Female, Male Male	63 Participants
Smoking Current smoker, less than one pack per day	19 Participants
Smoking Current smoker more than or equal to one pack/day	13 Participants
Smoking Never smoked or not smoked within last 10 yrs	54 Participants
Smoking Not a current smoker but has smoked in past 10 yrs	23 Participants
Smoking Unknown	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 112
other Total, other adverse events	51 / 112
serious Total, serious adverse events	39 / 112

Outcome results

Primary

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

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

Population: The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVM Treatment	Number of Participants With Catheter-related Adverse Events at 30 Days	0 Participants

Secondary

Number of Participants With Catheter-related Adverse Events at 12 Months

Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)

Time frame: 12 months