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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

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE March 4, 2015
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE May 18, 2015
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Incidence of catheter-related adverse events per Subject [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2019)
  • Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days [ Time Frame: 30 days ]
    Rate of premature (unintentional) catheter tip detachment
  • Number of Participants With Intentional Catheter Tip Detachment at 30 Days [ Time Frame: 30 days ]
    Rate of intentional catheter tip detachment
  • 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
  • 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
  • Number of Participants With Catheter-related Adverse Events at 30 Days [ Time Frame: 30 days ]
    Incidence of catheter-related adverse events at 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Acute Secondary Endpoints [ Time Frame: 30 days ]
    Rate of catheter tip detachment
  • Acute Secondary Endpoints [ Time Frame: 30 days ]
    Rate of migration of the retained catheter tip post embolization
  • Acute Secondary Endpoints [ Time Frame: 30 days ]
    Incidence of procedure-related adverse events
  • Acute Secondary Endpoints [ Time Frame: 30 days ]
    Rate of catheter/tip leakage from detachment zone
  • Long-Term Secondary Endpoints [ Time Frame: 12 months ]
    Incidence of adverse events (AEs)
  • Long-Term Secondary Endpoints [ Time Frame: 12 months ]
    Rate of migration of the retained catheter tip post embolization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Official Title  ICMJE Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arteriovenous Malformations
Intervention  ICMJE Device: Apollo™ Onyx™ Delivery Micro Catheter
Study Arms  ICMJE AVM treatment
Apollo™ Onyx™ Delivery Micro Catheter
Intervention: Device: Apollo™ Onyx™ Delivery Micro Catheter
Publications * 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 Feb 1. pii: neurintsurg-2020-016830. doi: 10.1136/neurintsurg-2020-016830. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2017)
112
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2015)
161
Actual Study Completion Date  ICMJE February 20, 2018
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02378883
Other Study ID Numbers  ICMJE NV-APL001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
Responsible Party Medtronic Neurovascular Clinical Affairs
Study Sponsor  ICMJE Medtronic Neurovascular Clinical Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohammed A Aziz-Sultan, MD Brigham and Women's Hospital
PRS Account Medtronic Neurovascular Clinical Affairs
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP