Axium Coil in Completing Endovascular Aneurysm Surgery Study
This trial is active, not recruiting.
|Treatment||microfx™ pgla coils|
|Start date||September 2010|
|End date||December 2011|
|Trial size||25 participants|
|Trial identifier||NCT01194388, ACCESS-09012010|
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.
Male or female participants from 18 years up to 90 years old.
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.
|Official title||Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry|
|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.|
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