Chronic Subdural Hematoma, Hemorrhage Brain
Conditions
Keywords
MMA Embolization, cSDH, Chronic Subdural Hematoma
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
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
DEVICEMatched 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.
DEVICESurgeon combination preference
Surgeon will decide the on guidewire and microcatheter to use for MMA embolization
Sponsors
Scientia Vascular, Inc.
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Navigation/procedure time | 2 years | Comparing between devices on both navigation and procedure time |
| Final Embolization Grades | 2 Years | Comparison between device groups for final embolization grades |
| Incidence of AE at time of surgery | 2 Years | Incidence of device related adverse events and incidence of procedure related adverse events |
| Incidence of recurrence of hemorrhage | 2 Years | Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up |
Countries
United States
Contacts
Primary ContactEdouard Belizaire
Outcome results
None listed