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To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Aneurysm Devices | Device | Intracranial Aneurysm occlusion |
| Measure | Description | Time Frame |
|---|---|---|
| RROC | Angiographic aneurysm occlusion (RROC) at 1 year | 1 year |
| RROC | Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) | 1 year |
| RROC | Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm | 1 year |
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Inclusion Criteria:
Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
Patient's IA will be treated using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the CAR study and prior to enrollment.
Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm.
Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.
Exclusion Criteria:
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Patients with ruptured or unruptured intracranial aneurysms who will be treated endovascularly with commercially available MicroVention devices at the direction of the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| TBD TBD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States | ||
| Orlando Health |
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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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| Orlando |
| Florida |
| 32806 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |