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| Name | Class |
|---|---|
| University of Florida | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axiumâ„¢ MicroFXâ„¢ PGLA Treated Subjects | This observational evaluation will evaluate early experience using the Axiumâ„¢ MicroFXâ„¢ PGLA COILS as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axiumâ„¢ Bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axiumâ„¢ MicroFXâ„¢ PGLA COILS | Device | Axiumâ„¢ MicroFXâ„¢ PGLA COILS to treat aneurysms |
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| Measure | Description | Time Frame |
|---|---|---|
| Anatomic occlusion of the aneurysm | Occlusion of aneurysm based on the Raymond classification | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety during the procedure | Morbidity and mortality rate | Discharge, up to two years |
| Safety post-procedure | Morbidity and mortality rate |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |