Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
- Conditions
- Arteriovenous Malformations
- Interventions
- Device: Apollo™ Onyx™ Delivery Micro Catheter
- Registration Number
- NCT02378883
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVM treatment Apollo™ Onyx™ Delivery Micro Catheter Apollo™ Onyx™ Delivery Micro Catheter
- Primary Outcome Measures
Name Time Method Number of Participants With Catheter-related Adverse Events at 30 Days 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
Name Time Method Number of Participants With Intentional Catheter Tip Detachment at 30 Days 30 days Rate of intentional catheter tip detachment
Number of Participants With Catheter-related Adverse Events at 30 Days 30 days Incidence of catheter-related adverse events at 30 days
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days 30 days Rate of premature (unintentional) catheter tip detachment
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days 30 days Rate of migration of the retained catheter tip post embolization
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months 12 months Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days 30 days Rate of catheter/tip leakage from detachment zone
Number of Participants With Catheter-related Adverse Events at 12 Months 12 months Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Trial Locations
- Locations (2)
Radiology Imaging Associates, P.C.
🇺🇸Englewood, Colorado, United States
Brigham's & Women Hospital
🇺🇸Boston, Massachusetts, United States