Collecting real-life data on endovascular treatments for brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MAESTRO-1 registry is a multicenter, non-interventional registry designed to gather real-world clinical data on the safety and effectiveness of Microvention implant devices used in the endovascular treatment of intracranial aneurysms. This observational study collects data electronically from patients treated for both ruptured and unruptured aneurysms using these devices. The information will be periodically reported to evaluate the performance of these CE-approved devices in clinical settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
  Vigo, Pontevedra, Spain Recruiting

Study contacts

• Study coordinator: Clinical Team
• Email: mveclinicalemea@microvention.com
• Phone: 0033139215220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.