Actively Recruiting
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Led by Ohio State University · Updated on 2026-01-07
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
S
Scientia Vascular, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a matched pair Aristotle 14 Guidewire and Plato Microcatheter compared to surgeon's preference devices in middle meningeal artery (MMA) embolization treatment for patients with chronic subdural hematoma. The study aims to assess the function of these devices during the embolization procedure for this condition. This early experience study is conducted at a single center to understand potential differences in device performance. Participants will be randomly assigned with equal chance to one of two groups. One group will undergo the embolization procedure using the study devices (matched pair Aristotle and Plato), while the other group will have the procedure performed using the devices chosen by their surgeon. The procedure and follow-up are part of standard medical care, so participation does not require extra time or effort beyond usual treatment. During the study, researchers will measure total navigation and procedure time, final embolization grades, incidence of adverse events at the time of surgery, and the rate of hemorrhage recurrence over two years. Participants' progress will be monitored through standard care visits without additional burden. The study is sponsored by Ohio State University and will run until July 2029.
CONDITIONS
Brief Title
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years old
- Patient or legally authorized representative signs an informed consent form
- Confirmed diagnosis of subacute or chronic subdural hematoma with 50% or more chronic blood
- Pre-morbid Modified Rankin Score of 64 3
You will not qualify if you...
- Age < 18 years old
- Potentially dangerous anatomic variations increasing risk or unsafe access for MMA embolization
- Unmanaged or uncontrolled bleeding disorders
- Presumed septic embolus or suspicion of microbial superinfection
- Contraindication to angiography
- CT or MRI evidence of intra-cranial tumor or mass lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo middle meningeal artery embolization using either study devices or devices chosen by their surgeon as part of standard medical care.
1 procedure visit (in-person)
Duration - Up to 2 years
Participants are observed as part of routine medical care following the embolization procedure.
Follow-up visits as part of standard care
Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
E
Edouard Belizaire
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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