About this trial
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
* Cohort 1: Patients with ruptured or unruptured intracranial aneurysms who are treated endovascularly with commercially available MicroVention implant devices at the direction of the treating physician * Cohort 2: Patients with acute ischemic stroke in the cerebral circulation who are treated with mechanical thrombectomy using selected commercially available Microvention devices, at the direction of the treating physician.
Trial design
Cohort
Prospective
Treatments tested in this trial
All Microvention Class III implantable device CE marked
DeviceEndovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.
All Microvention Mechanical Thrombectomy Class III device CE marked
DeviceEndovascular treatment of acute ischemic stroke with commercially available MicroVention devices.
Treatment groups
Trial outcomes
Primary outcomes
Cohort 1: Proportion of aneurysms with complete occlusion
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
based on independent Corelab assessment
Sponsors and contacts
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