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Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Primary Purpose

Arteriovenous Malformations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apollo™ Onyx™ Delivery Micro Catheter
Sponsored by
Medtronic Neurovascular Clinical Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Malformations focused on measuring Apollo, Onyx, Arteriovenous malformation, AVM, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter, Brain Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Radiology Imaging Associates, P.C.
  • Brigham's & Women Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AVM treatment

Arm Description

Apollo™ Onyx™ Delivery Micro Catheter

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2015
Last Updated
April 4, 2019
Sponsor
Medtronic Neurovascular Clinical Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT02378883
Brief Title
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Official Title
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2015 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Malformations
Keywords
Apollo, Onyx, Arteriovenous malformation, AVM, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter, Brain Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVM treatment
Arm Type
Other
Arm Description
Apollo™ Onyx™ Delivery Micro Catheter
Intervention Type
Device
Intervention Name(s)
Apollo™ Onyx™ Delivery Micro Catheter
Primary Outcome Measure Information:
Title
Number of Participants With Catheter-related Adverse Events at 30 Days
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
Description
Rate of premature (unintentional) catheter tip detachment
Time Frame
30 days
Title
Number of Participants With Intentional Catheter Tip Detachment at 30 Days
Description
Rate of intentional catheter tip detachment
Time Frame
30 days
Title
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
Description
Rate of migration of the retained catheter tip post embolization
Time Frame
30 days
Title
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
Description
Rate of catheter/tip leakage from detachment zone
Time Frame
30 days
Title
Number of Participants With Catheter-related Adverse Events at 30 Days
Description
Incidence of catheter-related adverse events at 30 days
Time Frame
30 days
Title
Number of Participants With Catheter-related Adverse Events at 12 Months
Description
Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Time Frame
12 months
Title
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
Description
Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Aziz-Sultan, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Imaging Associates, P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Brigham's & Women Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
Citations:
PubMed Identifier
33526480
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.
Results Reference
derived

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Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

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