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Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center | Clinical Trials | Clareo Health

RECRUITING

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

NCT07324551•Ohio State University

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Key Dates

Start Date

November 3, 2025

Primary Completion Date

July 1, 2028

Completion Date

July 1, 2029

Last Updated

January 7, 2026

Enrollment

100

ESTIMATED participants

Conditions

Chronic Subdural HematomaHemorrhage Brain

Interventions

Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

DEVICE

Surgeon combination preference

DEVICE

Contacts

Edouard Belizaire

CONTACT

614.366.6936 edouard.belizaire@osumc.edu

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

NCT06163547

Chronic Subdural HematomasCerebral Compression Due to Injury

View study

RECRUITINGNA

Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

NCT05374681

Chronic Subdural Hematoma

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)

Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

Registry of Chronic Subdural Hematoma

Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma

Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy

Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)