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Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378883
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arteriovenous Malformations Device: Apollo™ Onyx™ Delivery Micro Catheter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
AVM treatment
Apollo™ Onyx™ Delivery Micro Catheter
 Device: Apollo™ Onyx™ Delivery Micro Catheter


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days [ Time Frame: 30 days ]
    Rate of premature (unintentional) catheter tip detachment

  2. Number of Participants With Intentional Catheter Tip Detachment at 30 Days [ Time Frame: 30 days ]
    Rate of intentional catheter tip detachment

  3. 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

  4. 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

  5. Number of Participants With Catheter-related Adverse Events at 30 Days [ Time Frame: 30 days ]
    Incidence of catheter-related adverse events at 30 days

  6. 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)

  7. 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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378883


Locations
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United States, Colorado
Radiology Imaging Associates, P.C.
Englewood, Colorado, United States, 80112
United States, Massachusetts
Brigham's & Women Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Mohammed A Aziz-Sultan, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Medtronic Neurovascular Clinical Affairs:
Study Protocol and Statistical Analysis Plan  [PDF] August 5, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02378883    
Other Study ID Numbers: NV-APL001
First Posted: March 4, 2015    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Apollo
Onyx
Arteriovenous malformation
AVM
 Onyx™ Liquid Embolic System
Apollo™ Onyx™ Delivery Microcatheter
Brain Diseases
Additional relevant MeSH terms:
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Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases