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NCT Number: NCT07324551

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

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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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Hemorrhage Brain Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Edouard J Belizaire, BA

CONTACT

[email protected]

614-366-6936

CONTACT

6143666936

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

Device

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.

Surgeon combination preference

Device

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

Primary outcomes

  1. Total Navigation/procedure time

    Time frame: 2 years

    Comparing between devices on both navigation and procedure time

  2. Final Embolization Grades

    Time frame: 2 Years

    Comparison between device groups for final embolization grades

  3. Incidence of AE at time of surgery

    Time frame: 2 Years

    Incidence of device related adverse events and incidence of procedure related adverse events

  4. Incidence of recurrence of hemorrhage

    Time frame: 2 Years

    Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Edouard Belizaire

CONTACT

[email protected]

614.366.6936

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Scientia Vascular, Inc.

Registry information

Acronym: SCIENTIA

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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