Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

750 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria

1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
2. Patient will be treated 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 CAR study and prior to enrollment. Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
3. Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment and no later than 48 hours post procedure for emergent treatment of ruptured aneurysms.
4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.

Exclusion Criteria

1. Target aneurysm has been previously treated via surgical or endovascular means.
2. Patient is enrolled in another device or drug study in which participation could confound study results.
3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
4. Patient has been previously enrolled into this study.

Study population

Patients with ruptured or unruptured intracranial aneurysms who will be treated endovascularly with commercially available MicroVention devices at the direction of the treating physician.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (27)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

27 locations

Study team and timeline

Lead sponsor

Microvention-Terumo, Inc.

Study start

Feb 19, 2024 Actual

Primary completion

2029-01 Estimated

Study completion

2029-01 Estimated

First posted

Jan 22, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts