Collecting real-life data on endovascular treatments for brain aneurysms
Microvention Aneurysm & Stroke Real-life Data Collection
This study is collecting real-life information on how safe and effective a specific type of device is for treating brain aneurysms in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Microvention-Terumo, Inc. Industry-sponsored |
| Locations | 1 site (Vigo, Pontevedra) |
| Trial ID | NCT06494436 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients treated for a ruptured or unruptured intracranial aneurysm using a Microvention implant device.
Not a fit: Patients who are inaccessible for follow-up or participating in other conflicting studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of endovascular treatments for brain aneurysms, potentially leading to improved patient outcomes.
How similar studies have performed: Other studies have successfully utilized real-world data collection to evaluate medical devices, indicating that this approach is both valid and beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vigo, Pontevedra
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.