Recruiting

Aristotle 14 & Plato

Sponsor:

Ohio State University

Code:

NCT07324551

Conditions

Chronic Subdural Hematoma

Hemorrhage Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

Surgeon combination preference

Study Details

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

Study ID

NCT07324551

Start date

Nov 3, 2025

Status verified date

Nov, 2025

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Matched pair Aristotle 14 guidewire and Plato 17 microcatheter

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

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

Primary outcome measure

  • Total Navigation/procedure time [ Time Frame: 2 years ]
  • Final Embolization Grades [ Time Frame: 2 Years ]
  • Incidence of AE at time of surgery [ Time Frame: 2 Years ]
  • Incidence of recurrence of hemorrhage [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Edouard Belizaire

614.366.6936edouard.belizaire@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Edouard J Belizaire, BA

614-366-6936edouard.belizaire@osumc.edu

6143666936

More Information

Sponsor

Ohio State University

Last update posted

Jan 7, 2026

Last verified

Nov, 2025

Keywords

  • MMA Embolization
  • cSDH
  • Chronic Subdural Hematoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-01-07.