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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroFx⢠PGLA Treated Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroFx⢠PGLA COILS | Device | . 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. |
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 |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |