NCT01194388

Axium Coil in Completing Endovascular Aneurysm Surgery Study

Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.

Detailed description

Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFx™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	MicroFx™ PGLA COILS	. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable Coils as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-09-03
• Last updated: 2021-05-26

Locations

1 site across 1 country: United States