Status:
RECRUITING
Microvention AnEurysm & STroke Real-life Data cOllection
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Intracranial Aneurysm
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Eligibility:
All Genders
Brief Summary
The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry
Detailed Description
Electronic platform to collect real-world clinical data, evaluate and periodically report safety and effectiveness of CE approved and commercially available Microvention implant devices used for the e...
Eligibility Criteria
Inclusion
- Patient or legally authorized representative (LAR) is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
- Patient is treated for a ruptured or unruptured intracranial aneurysm 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 MAESTRO-1 study.
Exclusion
- Patient is or is expected to be inaccessible for follow-up.
- Patient is participating or intends to participate in another study that changes the site practice.
- Patient has been previously enrolled into the MAESTRO-1 study.
Key Trial Info
Start Date :
December 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06494436
Start Date
December 30 2024
End Date
June 30 2030
Last Update
January 9 2025
Active Locations (1)
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1
Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
Vigo, Pontevedra, Spain, 36312