Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Aneurysm Clinical Trial

— AMERICA  

Official title:

Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323439
• Other study ID #: AMERICA
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: August 28, 2017
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: August 2017
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

Description:

This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.

• Information on data collection provided to the patient or legally authorized representative and signed informed consent.

• Aneurysm diameter =10mm .

• Age range of 18 - 90.

Exclusion Criteria:

• Aneurysm previously treated.

• Aneurysm AVM related or dissecting.

• Participation in a clinical investigation of other aneurysm treating or related devices.

• Any condition that would preclude the conduct of protocol follow-up.

• Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Axium™ MicroFX™ PGLA COILS
Axium™ MicroFX™ PGLA COILS to treat aneurysms

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic occlusion of the aneurysm	Occlusion of aneurysm based on the Raymond classification	Immediately post-procedure
Secondary	Safety during the procedure	Morbidity and mortality rate	Discharge, up to two years
Secondary	Safety post-procedure	Morbidity and mortality rate	3-6 months follow-up
Secondary	Detachment system performance	Occurrence of detachment failure	During procedure
Secondary	Stability of embolization	Rate of change towards worsening Raymond grades	3-6 months follow-up
Secondary	Packing efficacy	increase in packing density calculated as ration between volume of coils and the aneurysm volume	36- months follow-up