Microvention Aneurysm & Stroke Real-life Data Collection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
Study Overview
Brief Summary
The MAESTRO 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 devices used for the endovascular treatment of Intracranial aneurysms and acute ischemic stroke.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms
Intervention: All Microvention Class III implantable device CE marked (Device)
2
Cohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke
Intervention: All Microvention Mechanical Thrombectomy Class III device CE marked (Device)
Outcomes
Primary Outcomes
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
Time Frame: Mechanical trombectomy Procedure
based on independent Corelab assessment
Cohort 1: Proportion of aneurysms with complete occlusion
Time Frame: 18 (±6) months
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory
Secondary Outcomes
No secondary outcomes reported