Intracranial AneurysmMAESTRONCT06494436
Microvention AnEurysm & STroke Real-life Data cOllection
An observational study of Intracranial Aneurysm and Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, run by Microvention-Terumo, Inc. at 1 site in Spain.
Trial summary
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- All Microvention Class III implantable device CE marked and All Microvention Mechanical Thrombectomy Class III device CE marked
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 30 Dec 2024to 30 Jun 2030
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Cohort 1: Patients with ruptured or unruptured intracranial aneurysms who are treated endovascularly with commercially available MicroVention implant devices at the direction of the treating physician * Cohort 2: Patients with acute ischemic stroke in the cerebral circulation who are treated with mechanical thrombectomy using selected commercially available Microvention devices, at the direction of the treating physician.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
Vigo, Pontevedra, 36312
Oscar Vila Nieto, MD
About this study
Official title: Microvention Aneurysm & Stroke Real-life Data Collection
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
Read the 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.
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke, Acute Ischemic Stroke
- Being tested
- All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked
- Keywords
- endovascular treatment, stent, flow diverter, hydrocoil, coil, implantable device, FRED, LVIS, WEB, Mechanical Thrombectomy, Aspiration, SOFIA, ERIC, BOBBY
- Medical subject headings
- Intracranial Aneurysm, Subarachnoid Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All Microvention Class III implantable device CE markedDevice
Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.
All Microvention Mechanical Thrombectomy Class III device CE markedDevice
Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms Receives: Device: All Microvention Class III implantable device CE marked | |
| 2 | Cohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke Receives: Device: All Microvention Mechanical Thrombectomy Class III device CE marked |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Proportion of aneurysms with complete occlusion
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory
Measured: 18 (±6) months
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
based on independent Corelab assessment
Measured: Mechanical trombectomy Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start30 Dec 2024
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandro Tomasello, MD, Study chair, University Hospital Vall D'HebronFranziska Dorn, Prof., Study chair, University Hospital, BonnSarah Power, MD, Study chair, Beaumont HospitalKrzysztof Kadziolka, MD, Study chair, John Paul II Independent Public Specialist Western HospitalGaultier Marnat, MD, Study chair, Hôpital Pellegrin, CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494436
- Sponsor's protocol ID
- MAESTRO
- Acronym
- MAESTRO
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential document. Only published data will be available
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvention Aneurysm & Stroke Real-life Data Collection
- ClinicalTrials.gov ID
- NCT06494436
- Acronym / sponsor ID
- MAESTRO / MAESTRO
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke, Acute Ischemic Stroke
- Keywords
- endovascular treatment, stent, flow diverter, hydrocoil, coil, implantable device, FRED, LVIS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: All Microvention Class III implantable device CE markedCohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms |
| 2 | – | Device: All Microvention Mechanical Thrombectomy Class III device CE markedCohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Cohort 1: Patients with ruptured or unruptured intracranial aneurysms who are treated endovascularly with commercially available MicroVention implant devices at the direction of the treating physician * Cohort 2: Patients with acute ischemic stroke in the cerebral circulation who are treated with mechanical thrombectomy using selected commercially available Microvention devices, at the direction of the treating physician.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All Microvention Class III implantable device CE markedEndovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices. | Device | 1 |
| All Microvention Mechanical Thrombectomy Class III device CE markedEndovascular treatment of acute ischemic stroke with commercially available MicroVention devices. | Device | 2 |
Primary outcome
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
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
Time frame: Mechanical trombectomy Procedure
based on independent Corelab assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. Confidential document. Only published data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Tomasello, MD study chair
University Hospital Vall D'Hebron
Franziska Dorn, Prof. study chair
University Hospital, Bonn
Sarah Power, MD study chair
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, run by Microvention-Terumo, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Team (0033139215220, mveclinicalemea@microvention.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Proportion of aneurysms with complete occlusion (time frame: 18 (±6) months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.