Microvention AnEurysm & STroke Real-life Data cOllection
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: All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke. 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
- Spain
- 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 →
Official title
Microvention Aneurysm & Stroke Real-life Data Collection
Overview
The MAESTRO 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 devices used for the endovascular treatment of Intracranial aneurysms and acute ischemic stroke.
Interventions
- Device All Microvention Class III implantable device CE marked
Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices. - Device All Microvention Mechanical Thrombectomy Class III device CE marked
Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.
Primary outcome measures
- Cohort 1: Proportion of aneurysms with complete occlusion [Time frame: 18 (±6) months]
- Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization [Time frame: Mechanical trombectomy Procedure]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology — Vigo
Identifiers
NCT: NCT06494436 · MAESTRO