Aneurysm Cerebral
Conditions
Brief summary
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.
Interventions
DEVICEIntracranial Aneurysm Devices
Intracranial Aneurysm occlusion
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate. 2. 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. 3. 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. 4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.
Exclusion criteria
1. Target aneurysm has been previously treated via surgical or endovascular means. 2. Patient is enrolled in another device or drug study in which participation could confound study results. 3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm). 4. Patient has been previously enrolled into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RROC | 1 year | Angiographic aneurysm occlusion (RROC) at 1 year |
Countries
United States
Outcome results
None listed