Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Arteriovenous Malformations Clinical Trial

Official title:

Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378883
• Other study ID #: NV-APL001
• Status: Completed
• Phase: N/A
• Start date: May 18, 2015
• Est. completion date: February 20, 2018

Study information

• Verified date: March 2019
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma

Intervention

Device:
• Apollo™ Onyx™ Delivery Micro Catheter

Locations

Country	Name	City	State
United States	Brigham's & Women Hospital	Boston	Massachusetts
United States	Radiology Imaging Associates, P.C.	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Catheter-related Adverse Events at 30 Days	Premature (unintentional) catheter tip detachment with clinical sequelae; Catheter rupture/break/fracture with clinical sequelae; Retained catheter body in the vasculature	30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Secondary	Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days	Rate of premature (unintentional) catheter tip detachment	30 days
Secondary	Number of Participants With Intentional Catheter Tip Detachment at 30 Days	Rate of intentional catheter tip detachment	30 days
Secondary	Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days	Rate of migration of the retained catheter tip post embolization	30 days
Secondary	Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days	Rate of catheter/tip leakage from detachment zone	30 days
Secondary	Number of Participants With Catheter-related Adverse Events at 30 Days	Incidence of catheter-related adverse events at 30 days	30 days
Secondary	Number of Participants With Catheter-related Adverse Events at 12 Months	Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)	12 months
Secondary	Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months	Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)	12 months