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RecruitingNCT06494436MAESTROUpdated Feb 9, 2026

Microvention AnEurysm & STroke Real-life Data cOllection

An observational study in Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion and Aneurysmal Subarachnoid Hemorrhage, sponsored by Microvention-Terumo, Inc.. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Microvention-Terumo, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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.

05

What researchers measure

Primary outcomes

  1. Cohort 1: Proportion of aneurysms with complete occlusion

    based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory

    Time frame: 18 (±6) months

  2. Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization

    based on independent Corelab assessment

    Time frame: Mechanical trombectomy Procedure

06

Study locations

1 of 1 sites recruiting
  • Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
    Vigo, Pontevedra 36312, Spain
    • Oscar Vila Nieto, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Confidential document. Only published data will be available

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06494436
Lead sponsor
Microvention-Terumo, Inc.
Responsible party
Sponsor
First posted
Jul 10, 2024
Start date
Dec 30, 2024
Primary completion
Dec 30, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Feb 9, 2026

Study contacts

Clinical Team
Contact
mveclinicalemea@microvention.com
0033139215220
Alejandro Tomasello, MD
study chair · University Hospital Vall D'Hebron
Franziska Dorn, Prof.
study chair · University Hospital, Bonn
Sarah Power, MD
study chair · Beaumont Hospital
Krzysztof Kadziolka, MD
study chair · John Paul II Independent Public Specialist Western Hospital
Gaultier Marnat, MD
study chair · Hôpital Pellegrin, CHU de Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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