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NCT01194388 Clinical Trial

Axium Coil in Completing Endovascular Aneurysm Surgery Study

Intracranial Aneurysm Clinical Trial

— ACCESS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01194388
Other study ID # ACCESS-09012010
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2010
Est. completion date February 2012

Study information
Verified date May 2021
Source Medtronic Neurovascular Clinical Affairs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2012
Est. primary completion date February 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

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