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| Name | Class |
|---|---|
| Semmes-Murphey Foundation | OTHER |
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To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is designed to determine the safety and occlusion rates of hydrogel coils in the ruptured aneurysm study population. Secondary objectives include determining clinical outcomes, packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with ruptured aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second-generation hydrogel coils | Device | Hydrogel coils 90% by length |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or major stroke | 30 days | |
| Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm | 18 months | |
| Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleed rate of the target aneurysm | 30 days | |
| Rebleed rate of the target aneurysm | 18 months | |
| Modified Rankin Score (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil embolization is determined to be the appropriate treatment strategy.
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| Name | Affiliation | Role |
|---|---|---|
| Adam S Arthur, MD, MPH, FACS | Semmes-Murphey Clinic | Principal Investigator |
| David Fiorella, MD, PhD | Stony Brook Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist University Hospital | Memphis | Tennessee | 38120 | United States |
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| ID | Term |
|---|---|
| D017542 | Aneurysm, Ruptured |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 18 months |
| Modified Rankin Score (mRS) | 30 days |
| Packing density measured by volumetric filling of the aneurysm | Immediately following procedure |
| Retreatment rate | 18 months |
| Retreatment rate due to recurrence | 18 months |
| Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm | 18 months |
| Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm | 18 months |
| Occlusion Stability (as defined by the Raymond Roy Occlusion Classification) | 18 months |
| Adverse events related to the device and/or the procedure | 18 months |