N/A
N=121
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
Arteriovenous Malformations
Bottom Line
View on ClinicalTrials.gov: NCT02378883 ↗Enrolled (actual)
121
Serious AEs
34.8%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Catheter-related Adverse Events at 30 Days — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Apollo™ Onyx™ Delivery Micro Catheter (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Catheter-related Adverse Events at 30 Days |
31 | — |
| SECONDARY Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days |
1 | — |
| SECONDARY Number of Participants With Intentional Catheter Tip Detachment at 30 Days |
68 | — |
| SECONDARY Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days |
— | — |
| SECONDARY Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days |
— | — |
| SECONDARY Number of Participants With Catheter-related Adverse Events at 30 Days |
31 | — |
| SECONDARY Number of Participants With Catheter-related Adverse Events at 12 Months |
68 | — |
| SECONDARY Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02378883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.