Microvention AnEurysm & STroke Real-life Data cOllection | NCT06494436

Studies
Microvention AnEurysm & STroke Real-life Data cOllection

NCT06494436

Sponsor

Microvention-Terumo, Inc.

Status

Recruiting

Last Update Posted

Feb 9, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Intracranial Aneurysm
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Aneurysmal Subarachnoid Hemorrhage
Ischemic Stroke
Acute Ischemic Stroke

Interventions

All Microvention Class III implantable device CE marked
All Microvention Mechanical Thrombectomy Class III device CE marked

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2024Actual

Primary Completion Date

Dec 30, 2029Estimated

Completion Date

Jun 30, 2030Estimated

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms	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	Device: All Microvention Mechanical Thrombectomy Class III device CE marked

Interventions

Name	Type	Description	Arm Group Labels	Other Names
All Microvention Class III implantable device CE marked	Device	Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort 1: Proportion of aneurysms with complete occlusion	based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory	18 (±6) months
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization	based on independent Corelab assessment	Mechanical trombectomy Procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Team	Contact	0033139215220		mveclinicalemea@microvention.com

Overall Officials

Name	Affiliation	Role
Alejandro Tomasello, MD	University Hospital Vall D'Hebron	Study Chair
Franziska Dorn, Prof.	University Hospital, Bonn	Study Chair
Sarah Power, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology	Recruiting	Vigo	Pontevedra	36312	Spain

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020300	Intracranial Hemorrhages
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D020521	Stroke

ID	Term
D002532	Intracranial Aneurysm
D013345	Subarachnoid Hemorrhage
D000083242	Ischemic Stroke