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The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DeltaMaxx treated Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeltaMaxx Microcoil System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Objective - Angiographic Outcomes | The Primary Effectiveness endpoint is the immediate post-procedure and 12-month angiographic occlusion rates assessed by the independent core lab using the modified Raymond-Roy Grading Scale (RRGS) scale | 12 Months |
| Primary Safety Endpoint - Neurological Morbidity and Mortality | Neurological Morbidity and Mortality as determined by the NIH Stroke Scale and all-cause mortality, regardless of relationship to the treatment, will be captured over the course of the study | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Packing Density | Packing density as measured by volumetric filling of the aneurysm post-procedure after the coils have been placed as indicated by angiographic films taken at the end of the coiling procedure | 24 hours |
| Recurrence Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have been diagnosed with a ≥ 6 mm intracranial aneurysm.
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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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| 12 months |
| Re-treatment Rate | 12 months |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |