Axium Coil in Completing Endovascular Aneurysm Surgery Study (ACCESS)
Recruitment status was Active, not recruiting
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry|
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|MicroFx™ PGLA Treated Subjects||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194388
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|