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OpenTrials
Recruiting

NCT Number: NCT06494436

Microvention AnEurysm & STroke Real-life Data cOllection

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

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

All Microvention Class III implantable device CE marked

Device

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

All Microvention Mechanical Thrombectomy Class III device CE marked

Device

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

Primary outcomes

  1. Cohort 1: Proportion of aneurysms with complete occlusion

    Time frame: 18 (±6) months

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

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

    Time frame: Mechanical trombectomy Procedure

    based on independent Corelab assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

0033139215220

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Acronym: MAESTRO

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Jul 10, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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