NCT01323439

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Aneurysm

Interventions

Type	Name	Description
DEVICE	Axium™ MicroFX™ PGLA COILS	Axium™ MicroFX™ PGLA COILS to treat aneurysms

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-03-25
• Last updated: 2017-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study