NCT02378883

Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Arteriovenous Malformations

Interventions

Type	Name	Description
DEVICE	Apollo™ Onyx™ Delivery Micro Catheter

Timeline

• Start date: 2015-05-18
• Primary completion: 2018-02-20
• Completion: 2018-02-20
• First posted: 2015-03-04
• Last updated: 2019-04-29
• Results posted: 2019-04-29

Locations

2 sites across 1 country: United States