Chronic Subdural HematomaSCIENTIANCT07324551
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
An observational study of Chronic Subdural Hematoma and Hemorrhage Brain, run by Ohio State University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Hemorrhage Brain
- What is being tested?
- Matched pair Aristotle 14 guidewire and Plato 17 microcatheter and Surgeon combination preference
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to The Ohio State University Wexner Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Edouard J Belizaire, BA, 614-366-6936, edouard.belizaire@osumc.edu
6143666936
About this study
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
Read the 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.
- Conditions
- Chronic Subdural Hematoma, Hemorrhage Brain
- Being tested
- Matched pair Aristotle 14 guidewire and Plato 17 microcatheter, Surgeon combination preference
- Keywords
- MMA Embolization, cSDH, Chronic Subdural Hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matched pair Aristotle 14 guidewire and Plato 17 microcatheterDevice
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 preferenceDevice
Surgeon will decide the on guidewire and microcatheter to use for MMA embolization
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Navigation/procedure time
Comparing between devices on both navigation and procedure time
Measured: 2 years
Final Embolization Grades
Comparison between device groups for final embolization grades
Measured: 2 Years
Incidence of AE at time of surgery
Incidence of device related adverse events and incidence of procedure related adverse events
Measured: 2 Years
Incidence of recurrence of hemorrhage
Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start3 Nov 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Scientia Vascular, Inc.
- Responsible party
- Principal investigator, Patrick Youssef, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324551
- Sponsor's protocol ID
- 20250580
- Acronym
- SCIENTIA
- Status last verified
- Nov 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
- ClinicalTrials.gov ID
- NCT07324551
- Acronym / sponsor ID
- SCIENTIA / 20250580
- Conditions
- Chronic Subdural Hematoma, Hemorrhage Brain
- Keywords
- MMA Embolization, cSDH, Chronic Subdural Hematoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Scientia Vascular, Inc.
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to The Ohio State University Wexner Medical Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matched pair Aristotle 14 guidewire and Plato 17 microcatheterParticipants 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. | Device | – |
| Surgeon combination preferenceSurgeon will decide the on guidewire and microcatheter to use for MMA embolization | Device | – |
Primary outcome
Total Navigation/procedure time
Time frame: 2 years
Comparing between devices on both navigation and procedure time
Final Embolization Grades
Time frame: 2 Years
Comparison between device groups for final embolization grades
Incidence of AE at time of surgery
Time frame: 2 Years
Incidence of device related adverse events and incidence of procedure related adverse events
Incidence of recurrence of hemorrhage
Time frame: 2 Years
Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma and Hemorrhage Brain, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edouard Belizaire (614.366.6936, edouard.belizaire@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Navigation/procedure time (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.