Status:
ENROLLING_BY_INVITATION
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Aneurysm Cerebral
Eligibility:
All Genders
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 aneury...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 8 2029
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06215105
Start Date
January 8 2024
End Date
January 8 2029
Last Update
October 1 2025
Active Locations (5)
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1
Memorial Healthcare System
Hollywood, Florida, United States, 33021
2
Orlando Health
Orlando, Florida, United States, 32806
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407