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| Name | Class |
|---|---|
| Scientia Vascular, Inc. | UNKNOWN |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matched pair Aristotle 14 guidewire and Plato 17 microcatheter | Device | 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 | Device | Surgeon will decide the on guidewire and microcatheter to use for MMA embolization |
| Measure | Description | Time Frame |
|---|---|---|
| Total Navigation/procedure time | Comparing between devices on both navigation and procedure time | 2 years |
| Final Embolization Grades | Comparison between device groups for final embolization grades | 2 Years |
| Incidence of AE at time of surgery | Incidence of device related adverse events and incidence of procedure related adverse events | 2 Years |
| Incidence of recurrence of hemorrhage | Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to The Ohio State University Wexner Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edouard Belizaire | Contact | 614.366.6936 | edouard.belizaire@osumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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