Acute Ischemic Stroke, Aneurysmal Subarachnoid Hemorrhage, Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Ischemic Stroke
Conditions
Keywords
endovascular treatment, stent, flow diverter, hydrocoil, coil, implantable device, FRED, LVIS, WEB, Mechanical Thrombectomy, Aspiration, SOFIA, ERIC, BOBBY
Brief summary
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
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.
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization | Mechanical trombectomy Procedure | based on independent Corelab assessment |
| Cohort 1: Proportion of aneurysms with complete occlusion | 18 (±6) months | based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory |
Countries
Spain
Contacts
CONTACTClinical Team
STUDY_CHAIRAlejandro Tomasello, MD
University Hospital Vall D'Hebron
STUDY_CHAIRFranziska Dorn, Prof.
Bonn University Hospital
STUDY_CHAIRSarah Power, MD
Beaumont Hospital
STUDY_CHAIRKrzysztof Kadziolka, MD
John Paul II Independent Public Specialist Western Hospital
STUDY_CHAIRGaultier Marnat, MD
Hôpital Pellegrin, CHU de Bordeaux
Outcome results
None listed