Microvention AnEurysm & STroke Real-life Data cOllection

NCT ID: NCT06494436

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-30

Study Completion Date

2030-06-30

Brief Summary

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The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry

Detailed Description

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Electronic platform to collect real-world clinical data, evaluate and periodically report safety and effectiveness of CE approved and commercially available Microvention implant devices used for the endovascular treatment of Intracranial aneurysms.

Conditions

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Intracranial Aneurysm Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion Aneurysmal Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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All Microvention Class III implantable device CE marked

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient or legally authorized representative (LAR) is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
* 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-1 study.

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 has been previously enrolled into the MAESTRO-1 study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Microvention-Terumo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Tomasello, MD

Role: STUDY_CHAIR

University Hospital Vall D'Hebron

Franziska Dorn, Prof.

Role: STUDY_CHAIR

Bonn University Hospital

Sarah Power, MD

Role: STUDY_CHAIR

Beaumont Hospital

Krzysztof Kadziolka, MD

Role: STUDY_CHAIR

John Paul II Independent Public Specialist Western Hospital

Gaultier Marnat, MD

Role: STUDY_CHAIR

Hôpital Pellegrin, CHU de Bordeaux

Locations

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

Vigo, Pontevedra, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Clinical Team

Role: CONTACT

0033139215220

Facility Contacts

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Oscar Vila Nieto, MD

Role: primary

Other Identifiers

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MAESTRO-1

Identifier Type: -

Identifier Source: org_study_id

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