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Completed

NCT Number: NCT02378883

Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

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.

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Key information

Conditions

Arteriovenous Malformations Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Vascular Diseases Vascular Malformations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiology Imaging Associates, P.C., Englewood, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apollo™ Onyx™ Delivery Micro Catheter

Device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2015
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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