Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Matched pair Aristotle 14 guidewire and Plato 17 microcatheter, Surgeon combination preference.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma, Hemorrhage Brain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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. - Device Surgeon combination preference
Surgeon will decide the on guidewire and microcatheter to use for MMA embolization
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT07324551 · 20250580