Microvention AnEurysm & STroke Real-life Data cOllection (MAESTRO)

Microvention Aneurysm & Stroke Real-life Data Collection

The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Acute Ischemic Stroke; Aneurysmal Subarachnoid Hemorrhage; Intracranial Aneurysm; Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
• Intervention / Treatment: Device: All Microvention Class III implantable device CE marked; Device: All Microvention Mechanical Thrombectomy Class III device CE marked

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Clinical Team; Phone Number: 0033139215220; Email: mveclinicalemea@microvention.com

Study Locations

• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Recruiting
      • Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
      • Contact: Oscar Vila Nieto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms	Device: All Microvention Class III implantable device CE marked; Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.
2; Cohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke	Device: All Microvention Mechanical Thrombectomy Class III device CE marked; Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Proportion of aneurysms with complete occlusion	based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory	18 (±6) months
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization	based on independent Corelab assessment	Mechanical trombectomy Procedure

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Study Chair: Alejandro Tomasello, MD, University Hospital Vall d'Hebron; Study Chair: Franziska Dorn, Prof., Bonn University Hospital; Study Chair: Sarah Power, MD, Beaumont Hospital; Study Chair: Krzysztof Kadziolka, MD, John Paul II Independent Public Specialist Western Hospital; Study Chair: Gaultier Marnat, MD, Hôpital Pellegrin, CHU de Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Aspiration; endovascular treatment; stent; coil; WEB; Mechanical Thrombectomy; flow diverter; implantable device; hydrocoil; FRED; LVIS; ERIC; SOFIA; BOBBY
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Arterial Diseases; Aneurysm; Intracranial Hemorrhages; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Subarachnoid Hemorrhage; Intracranial Aneurysm
• Other Study ID Numbers: MAESTRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidential document. Only published data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No