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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma; Hemorrhage Brain
• Intervention / Treatment: Device: Matched pair Aristotle 14 guidewire and Plato 17 microcatheter; Device: Surgeon combination 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Edouard Belizaire; Phone Number: 614.366.6936; Email: edouard.belizaire@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Edouard J Belizaire, BA; Phone Number: 614-366-6936; Email: edouard.belizaire@osumc.edu
      • Contact: Phone Number: 6143666936

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to The Ohio State University Wexner Medical Center

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Navigation/procedure time	Comparing between devices on both navigation and procedure time	2 years
Final Embolization Grades	Comparison between device groups for final embolization grades	2 Years
Incidence of AE at time of surgery	Incidence of device related adverse events and incidence of procedure related adverse events	2 Years
Incidence of recurrence of hemorrhage	Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up	2 Years

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Scientia Vascular, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Subdural Hematoma; cSDH; MMA Embolization
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic; Intracranial Hemorrhages
• Other Study ID Numbers: 20250580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No