RecruitingNCT06494436
Microvention AnEurysm & STroke Real-life Data cOllection
Microvention Aneurysm & Stroke Real-life Data Collection
Sponsor
Microvention-Terumo, Inc.
Enrollment
1,000 participants
Start Date
Dec 30, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
Eligibility
Inclusion Criteria4
- Patient, or another authorized person as per country-specific regulations, is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
- For Cohort 1, 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 study.
- For Cohort 2, patient is treated using a commercially available MicroVention mechanical thrombectomy device as the first-line treatment strategy and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.
- Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters, carotid stent for extracranial stenosis and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
Exclusion Criteria3
- 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 is already participating in the MAESTRO study for the same pathology.
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Interventions
DEVICEAll Microvention Class III implantable device CE marked
Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.
DEVICEAll Microvention Mechanical Thrombectomy Class III device CE marked
Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06494436
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