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
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Malformations||Device: Apollo™ Onyx™ Delivery Micro Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Apollo™ Onyx™ Delivery Micro Catheter
Device: Apollo™ Onyx™ Delivery Micro Catheter
- 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
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
|Principal Investigator:||Mohammed A Aziz-Sultan, MD||Brigham and Women's Hospital|
Documents provided by Medtronic Neurovascular Clinical Affairs:
|Responsible Party:||Medtronic Neurovascular Clinical Affairs|
|Other Study ID Numbers:||
|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.|
Onyx™ Liquid Embolic System
Apollo™ Onyx™ Delivery Microcatheter