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Microvention Aneurysm & Stroke Real-life Data Collection

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
RECRUITING
Vigo
Contact Information
Primary
Clinical Team
mveclinicalemea@microvention.com
0033139215220
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 1000
Treatments
1
Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms
2
Cohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke
Sponsors
Leads: Microvention-Terumo, Inc.

This content was sourced from clinicaltrials.gov

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