Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

April 4, 2019 updated by: Medtronic Neurovascular Clinical Affairs
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Radiology Imaging Associates, P.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham's & Women Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AVM treatment
Apollo™ Onyx™ Delivery Micro Catheter
Device: Apollo™ Onyx™ Delivery Micro Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Catheter-related Adverse Events at 30 Days
Time Frame: 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
30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Principal Investigator: Mohammed A Aziz-Sultan, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2015

Primary Completion (Actual)

February 20, 2018

Study Completion (Actual)

February 20, 2018

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV-APL001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arteriovenous Malformations

Clinical Trials on Apollo™ Onyx™ Delivery Micro Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe