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

NCT07324551 | Recruiting FDA Device

• 1 other identifier: 20250580
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Subdural Hematoma; Hemorrhage Brain

Keywords

MMA Embolization; cSDH; Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to The Ohio State University Wexner Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Scientia Vascular, Inc.: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Edouard Belizaire

CONTACT

614.366.6936; edouard.belizaire@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: November 3, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)