Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intracranial Aneurysm Devices.
- Who it may be relevant to
- Registry conditions: Aneurysm Cerebral. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Intracranial Aneurysm Devices
Intracranial Aneurysm occlusion
Primary outcome measures
- RROC [Time frame: 1 year]
- RROC [Time frame: 1 year]
- RROC [Time frame: 1 year]
Eligibility criteria
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
- Target aneurysm has been previously treated via surgical or endovascular means.
- Patient is enrolled in another device or drug study in which participation could confound study results.
- Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
- Patient has been previously enrolled into this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- Memorial Healthcare System — Hollywood
- Orlando Health — Orlando
- University of Iowa — Iowa City
- Abbott Northwestern Hospital — Minneapolis
- Albany Medical Center — Albany
Identifiers
NCT: NCT06215105 · CL11025