Axium Coil in Completing Endovascular Aneurysm Surgery Study

Withdrawn

• Conditions: Intracranial Aneurysm
• Interventions: Device: MicroFx™ PGLA COILS

• Registration Number: NCT01194388
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

Brief 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-03
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MicroFx™ PGLA Treated Subjects	MicroFx™ PGLA COILS	-

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States