Aneurysm
Conditions
Keywords
Patients presenting with an intracranial aneurysm
Brief summary
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
Detailed description
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.
Interventions
DEVICEAxium™ MicroFX™ PGLA COILS
Axium™ MicroFX™ PGLA COILS to treat aneurysms
Sponsors
University of Florida
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic occlusion of the aneurysm | Immediately post-procedure | Occlusion of aneurysm based on the Raymond classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety during the procedure | Discharge, up to two years | Morbidity and mortality rate |
| Safety post-procedure | 3-6 months follow-up | Morbidity and mortality rate |
| Detachment system performance | During procedure | Occurrence of detachment failure |
| Stability of embolization | 3-6 months follow-up | Rate of change towards worsening Raymond grades |
| Packing efficacy | 36- months follow-up | increase in packing density calculated as ration between volume of coils and the aneurysm volume |
Countries
United States
Outcome results
None listed