Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Study Overview
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Brief Summary
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This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.

Detailed Description
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This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification. Secondary endpoints included safety during the procedure, safety after the procedure, detachment system performance, stability of the embolization, and packing efficacy.

Official Title
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Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study

Conditions
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Aneurysm

Intervention / Treatment
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* Device: Axium™ MicroFX™ PGLA COILS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axium™ MicroFX™ PGLA Treated Subjects<br>This observational evaluation will evaluate early experience using the Axium™ MicroFX™ PGLA 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 | Device: Axium™ MicroFX™ PGLA COILS<br>* Axium™ MicroFX™ PGLA COILS to treat aneurysms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic occlusion of the aneurysm | Occlusion of aneurysm based on the Raymond classification | Immediately post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during the procedure | Morbidity and mortality rate | Discharge, up to two years | 
| Safety post-procedure | Morbidity and mortality rate | 3-6 months follow-up | 
| Detachment system performance | Occurrence of detachment failure | During procedure | 
| Stability of embolization | Rate of change towards worsening Raymond grades | 3-6 months follow-up | 
| Packing efficacy | increase in packing density calculated as ration between volume of coils and the aneurysm volume | 36- months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients presenting with an intracranial aneurysm