Microvention AnEurysm & STroke Real-life Data cOllection

NCT06494436 | Recruiting

• 1 other identifier: MAESTRO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysm; Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion; Aneurysmal Subarachnoid Hemorrhage; Ischemic Stroke; Acute Ischemic Stroke

Keywords

endovascular treatment; stent; flow diverter; hydrocoil; coil; implantable device; FRED; LVIS; WEB; Mechanical Thrombectomy; Aspiration; SOFIA; ERIC; BOBBY

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

All Microvention Class III implantable device CE marked DEVICE

Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.

1

All Microvention Mechanical Thrombectomy Class III device CE marked DEVICE

Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology

Vigo, Pontevedra, 36312, Spain

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Alejandro Tomasello, MD

  University Hospital Vall D'Hebron

  STUDY CHAIR

• Franziska Dorn, Prof.

  University Hospital, Bonn

  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 CHAIR

Central Study Contacts

Clinical Team

CONTACT

0033139215220; mveclinicalemea@microvention.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)