Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center (SCIENTIA)

The Ohio State University

Status: Enrolling

Conditions: Hemorrhage Brain; Chronic Subdural Hematoma

Treatments: Device: Surgeon combination preference; Device: Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

Study type: Observational

Funder types: Other

Identifiers

NCT07324551

20250580

Details and patient eligibility

About

The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference

Full description

If you agree to take part, you will have a 50/50 chance of being assigned to one of two groups. In group 1, your procedure will use the study devices. In group 2, your procedure will use devices chosen by your surgeon. The procedure and follow up are part of standard medical care. This means that taking part in the study will not mean more time or energy compared to the usual treatment you would have.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Patient or legally authorized representative (LAR) signs an informed consent form
• Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood
• Pre-morbid Modified Rankin Score of ≤ 3

Exclusion criteria

• Age < 18 years old
• Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
• Unmanaged, uncontrolled bleeding disorders/blood diathesis
• Presumed septic embolus, or suspicion of microbial superinfection
• Contraindication to angiography
• CT or MRI evidence of intra-cranial tumor or mass lesion