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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-03

Study Completion Date

2029-07-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Subdural Hematoma Hemorrhage Brain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

Participants will be randomized in 1:1 ratio to either use of study devices (matched pair Aristotle and Plato) or standard of care (surgeon combination preference) using block randomization method with a fixed block size of 4 ensuring 50% will be randomized to study devices group and 50% randomized to standard of care group.

Intervention Type DEVICE

Surgeon combination preference

Surgeon will decide the on guidewire and microcatheter to use for MMA embolization

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No