Microvention AnEurysm & STroke Real-life Data cOllection
Recruiting
- Conditions
- Intracranial AneurysmIntracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm LesionAneurysmal Subarachnoid Hemorrhage
- Registration Number
- NCT06494436
- Lead Sponsor
- Microvention-Terumo, Inc.
- Brief Summary
The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of aneurysms with complete occlusion 18 (±6) months based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
🇪🇸Vigo, Pontevedra, Spain